Trial Outcomes & Findings for Opioid Prescribing After Cesarean Delivery (NCT NCT03168425)
NCT ID: NCT03168425
Last Updated: 2019-06-03
Results Overview
oxycodone 5mg tablet leftover from prescription at discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
4 weeks postpartum
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
Tailored
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
|
Control
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
96
|
|
Overall Study
COMPLETED
|
87
|
85
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Tailored
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
|
Control
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
unable to confirm post op opioids
|
2
|
3
|
Baseline Characteristics
7 tailored/ 11 control subjects lost to follow-up
Baseline characteristics by cohort
| Measure |
Tailored
n=94 Participants
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
|
Control
n=96 Participants
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 5.9 • n=87 Participants • 7 tailored/ 11 control subjects lost to follow-up
|
30.4 years
STANDARD_DEVIATION 5.8 • n=85 Participants • 7 tailored/ 11 control subjects lost to follow-up
|
30.4 years
STANDARD_DEVIATION 2.8 • n=172 Participants • 7 tailored/ 11 control subjects lost to follow-up
|
|
Sex: Female, Male
Female
|
87 Participants
n=87 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
85 Participants
n=85 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
172 Participants
n=172 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
|
Sex: Female, Male
Male
|
0 Participants
n=87 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
0 Participants
n=85 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
0 Participants
n=172 Participants • 7 Tailored/ 11 control subjects lost to follow-up
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
1 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
7 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
9 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
27 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
White
|
53 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
60 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
113 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
0 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=87 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
15 Participants
n=85 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
25 Participants
n=172 Participants • 11 Tailored/ 7 control subjects were lost to follow-up
|
|
Region of Enrollment
United States
|
87 participants
n=87 Participants • 7 Tailored/ 11 Control subjects lost to follow-up
|
85 participants
n=85 Participants • 7 Tailored/ 11 Control subjects lost to follow-up
|
172 participants
n=172 Participants • 7 Tailored/ 11 Control subjects lost to follow-up
|
PRIMARY outcome
Timeframe: 4 weeks postpartumoxycodone 5mg tablet leftover from prescription at discharge
Outcome measures
| Measure |
Tailored
n=87 Participants
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Participants who received an individualized prescription were discharged with 14 \[interquartile range 12-16\] oxycodone 5mg tablets.
|
Control
n=85 Participants
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
|---|---|---|
|
Unused Opioids
|
5 oxycodone 5mg tablets
Interval 1.0 to 8.0
|
10 oxycodone 5mg tablets
Interval 0.0 to 22.0
|
SECONDARY outcome
Timeframe: 4 weeks postpartumFrequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0)
Outcome measures
| Measure |
Tailored
n=87 Participants
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Participants who received an individualized prescription were discharged with 14 \[interquartile range 12-16\] oxycodone 5mg tablets.
|
Control
n=85 Participants
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
|---|---|---|
|
Pain: Frequency That Participants Reported Uncontrolled Pain
|
4 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
Adverse Events
Tailored
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tailored
n=94 participants at risk
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
|
Control
n=96 participants at risk
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Surgical Site Infection
|
1.1%
1/94 • Number of events 1 • 4 weeks
|
0.00%
0/96 • 4 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Sarah Osmundson, MD
Vanderbilt University Medical Center
Phone: +1 (615) 343-5700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place