Trial Outcomes & Findings for Pregabalin vs. Gabapentin on Reducing Opioid Usage (NCT NCT04705480)
NCT ID: NCT04705480
Last Updated: 2026-01-06
Results Overview
To determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Results posted on
2026-01-06
Participant Flow
This study was conducted at a tertiary, academic Level I trauma center located in the southeastern region of the United States between 2021-2024. Patients included in this trial were admitted under the care of the Trauma Nurse Practitioners (TNPs) who lead management of these patients. Screening for eligibility based on inclusion and exclusion criteria , enrollment and consenting of participants were performed by the research coordinators.
Participant milestones
| Measure |
Pregabalin
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
33
|
33
|
|
Overall Study
COMPLETED
|
38
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
3
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
|
Overall Study
Decision to discharge before intervention
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Pre-existing Cardiovascular Disease
|
25 Participants
n=38 Participants
|
21 Participants
n=33 Participants
|
25 Participants
n=30 Participants
|
71 Participants
n=101 Participants
|
|
Age, Continuous
|
60 years
n=38 Participants
|
63 years
n=33 Participants
|
72 years
n=30 Participants
|
61 years
n=101 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=38 Participants
|
21 Participants
n=33 Participants
|
23 Participants
n=30 Participants
|
70 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=38 Participants
|
12 Participants
n=33 Participants
|
7 Participants
n=30 Participants
|
31 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
33 participants
n=33 Participants
|
30 participants
n=30 Participants
|
101 participants
n=101 Participants
|
|
Body Mass Index
|
30 kg/m²
n=38 Participants
|
30 kg/m²
n=33 Participants
|
28 kg/m²
n=30 Participants
|
30 kg/m²
n=101 Participants
|
|
Days of enrollment
|
2 days
n=38 Participants
|
3 days
n=33 Participants
|
4 days
n=30 Participants
|
3 days
n=101 Participants
|
|
Patients with rib fracture
|
3 Participants
n=38 Participants
|
2 Participants
n=33 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=101 Participants
|
|
Time from enrollment to first dose of study drug
|
4 hours
n=38 Participants
|
2 hours
n=33 Participants
|
0 hours
n=30 Participants
|
3 hours
n=101 Participants
|
|
Patients underwent surgery
|
34 Participants
n=38 Participants
|
28 Participants
n=33 Participants
|
26 Participants
n=30 Participants
|
88 Participants
n=101 Participants
|
|
Opioids as home medication
|
2 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=101 Participants
|
|
Pre-existing Diabetes
|
5 Participants
n=38 Participants
|
9 Participants
n=33 Participants
|
9 Participants
n=30 Participants
|
23 Participants
n=101 Participants
|
|
Pre-existing Smoker
|
9 Participants
n=38 Participants
|
6 Participants
n=33 Participants
|
5 Participants
n=30 Participants
|
20 Participants
n=101 Participants
|
|
Pre-existing Psychiatric
|
5 Participants
n=38 Participants
|
8 Participants
n=33 Participants
|
0 Participants
n=30 Participants
|
13 Participants
n=101 Participants
|
|
Pre-existing Pulmonary
|
1 Participants
n=38 Participants
|
1 Participants
n=33 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=101 Participants
|
|
Pre-existing Hematologic
|
2 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=101 Participants
|
|
Pre-existing Autoimmune
|
1 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=101 Participants
|
|
Pre-existing Neurological
|
1 Participants
n=38 Participants
|
2 Participants
n=33 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=101 Participants
|
|
Pre-existing Gastrointestinal
|
0 Participants
n=38 Participants
|
2 Participants
n=33 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=101 Participants
|
|
Pre-existing Malignancy
|
0 Participants
n=38 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=101 Participants
|
|
Pre-existing Other
|
1 Participants
n=38 Participants
|
3 Participants
n=33 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollmentTo determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.
Outcome measures
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Reduction in Opioid Usage
|
69.5 MME
Interval 35.0 to 115.0
|
81 MME
Interval 30.0 to 150.0
|
66.3 MME
Interval 45.0 to 120.8
|
SECONDARY outcome
Timeframe: Initial and last incentive spirometry, with an approximate duration of 7days or discharge; if discharge < 7 days post-enrollment.Population: The number in each arm does not match the number in the arms of the overall study as this outcomes measure pertains to those with rib fracture only.
To compare the difference between the initial and last documented incentive spirometry values (mL) among patients in each of the study groups who have at least 1 rib fracture.
Outcome measures
| Measure |
Pregabalin
n=3 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=2 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=3 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Difference in Initial and Last Incentive Spirometry Values
|
400 mL
Interval 300.0 to 500.0
|
0 mL
Interval 0.0 to 0.0
|
250 mL
Interval 250.0 to 250.0
|
SECONDARY outcome
Timeframe: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollmentTo compare the proportion of patients requiring intubation among the study groups.
Outcome measures
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Rate of Intubation
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollmentTo assess effectiveness of pain control in each arm based on the average Numeric Pain Rating Scale score per 24 hours. This scale is a 10 point numeric scale that ranges from 0 that represents "no pain" to 10 which indicates the "worst pain imaginable."
Outcome measures
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Pain Control
|
6.4 Average score on numeric pain scale/day
Interval 6.0 to 7.0
|
6.2 Average score on numeric pain scale/day
Interval 5.8 to 7.0
|
6.2 Average score on numeric pain scale/day
Interval 5.8 to 6.6
|
SECONDARY outcome
Timeframe: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollmentTo evaluate the differences among the study arms with respect to hospital length of stay (days).
Outcome measures
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Hospital Length of Stay
|
3.0 days
Interval 2.0 to 5.6
|
4.0 days
Interval 2.0 to 6.8
|
4.3 days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollmentPopulation: While enrolled, no patients in the pregabalin or neither group required ICU admission or intubation, however, these events occurred in 2 patients (6.1%) in the gabapentin group. These unplanned ICU upgrades were not due to the study medications.
To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.
Outcome measures
| Measure |
Pregabalin
n=38 Participants
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Gabapentin
n=33 Participants
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 Participants
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
|---|---|---|---|
|
Rate of Unplanned ICU Admission
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Gabapentin
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Neither Pregabalin Nor Gabapentin
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Pregabalin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gabapentin
n=33 participants at risk
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 participants at risk
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
Pregabalin
n=38 participants at risk
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/33 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/30 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
2.6%
1/38 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
General disorders
hallucination or confusion
|
3.0%
1/33 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
3.3%
1/30 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/33 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
6.7%
2/30 • Number of events 2 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Surgical and medical procedures
post surgical complication
|
3.0%
1/33 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/30 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Gastrointestinal disorders
Pneumatosis of colon requiring surgery
|
3.0%
1/33 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/30 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
Other adverse events
| Measure |
Gabapentin
n=33 participants at risk
Gabapentin 300mg: Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
Neither Pregabalin Nor Gabapentin
n=30 participants at risk
Neither Pregabalin nor Gabapentin: Patients will receive neither Pregabalin nor Gabapentin.
|
Pregabalin
n=38 participants at risk
Pregabalin 50mg: Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl \< 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if \< 7 days post-enrollment).
|
|---|---|---|---|
|
General disorders
buccal ulcer
|
3.0%
1/33 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/30 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
6.7%
2/30 • Number of events 2 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Nervous system disorders
dizziness and/or somnolence
|
3.0%
1/33 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
3.3%
1/30 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
General disorders
Hypotension
|
0.00%
0/33 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/30 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
2.6%
1/38 • Number of events 1 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
6.7%
2/30 • Number of events 2 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
0.00%
0/38 • Up to 7 days or discharge, whichever occurred first
Study coordinators monitored charts for any adverse events post enrollment for 7 days or until discharge, whichever occurred first. These were reported to the PI and classified as serious or not, and reported to the IRB accordingly. Most were felt to be unrelated to study drugs. Only those reported as dizziness, somnolence or confusion were felt to possibly be related and study medications were stopped. All adverse events resolved prior to discharge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place