Trial Outcomes & Findings for Satisfactory Analgesia Minimal Emesis in Day Surgeries (NCT NCT02223377)
NCT ID: NCT02223377
Last Updated: 2023-12-11
Results Overview
Our combined primary outcome will be number of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
At 2hrs or at the time of discharge from PACU
Results posted on
2023-12-11
Participant Flow
Participant milestones
| Measure |
Morphine
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
203
|
|
Overall Study
COMPLETED
|
199
|
203
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=203 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=199 Participants
|
0 Participants
n=203 Participants
|
0 Participants
n=402 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=199 Participants
|
175 Participants
n=203 Participants
|
357 Participants
n=402 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=199 Participants
|
28 Participants
n=203 Participants
|
45 Participants
n=402 Participants
|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 13.8 • n=199 Participants
|
47.1 years
STANDARD_DEVIATION 14.0 • n=203 Participants
|
46.6 years
STANDARD_DEVIATION 13.9 • n=402 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=199 Participants
|
126 Participants
n=203 Participants
|
258 Participants
n=402 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=199 Participants
|
77 Participants
n=203 Participants
|
144 Participants
n=402 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
199 Participants
n=199 Participants
|
203 Participants
n=203 Participants
|
402 Participants
n=402 Participants
|
|
Body Mass Index (BMI)
|
27.55 kg/m^2
STANDARD_DEVIATION 4.00 • n=199 Participants
|
27.06 kg/m^2
STANDARD_DEVIATION 4.27 • n=203 Participants
|
27.37 kg/m^2
STANDARD_DEVIATION 4.14 • n=402 Participants
|
|
Apfel score
|
2.6 units on a scale
STANDARD_DEVIATION 0.9 • n=199 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.0 • n=203 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.9 • n=402 Participants
|
|
Depression score
|
2 units on a scale
n=199 Participants
|
2 units on a scale
n=203 Participants
|
2 units on a scale
n=402 Participants
|
|
Anxiety score
|
6 units on a scale
n=199 Participants
|
6 units on a scale
n=203 Participants
|
6 units on a scale
n=402 Participants
|
|
Catastrophising score
|
9 units on a scale
n=199 Participants
|
10 units on a scale
n=203 Participants
|
9 units on a scale
n=402 Participants
|
|
Preoperative pain in the operative area
|
83 Participants
n=199 Participants
|
83 Participants
n=203 Participants
|
166 Participants
n=402 Participants
|
|
Chronic pain in other areas
|
35 Participants
n=199 Participants
|
33 Participants
n=203 Participants
|
68 Participants
n=402 Participants
|
PRIMARY outcome
Timeframe: At 2hrs or at the time of discharge from PACUOur combined primary outcome will be number of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse.
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups.
|
172 Participants
|
175 Participants
|
SECONDARY outcome
Timeframe: At 2hrs or at the time of discharge from PACUSevere itching measured as visual analog scale score \> 5 on a 0-10 Visual Analog Scale, where 0 = no itching, and 10 = worst itching imaginable
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Number of Patients With Severe Itching
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At 2hrs or at the time of discharge from PACURamsay Sedation Scale 0-6
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Severe Sedation
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At 2hrs or at the time of discharge from PACUPresence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation \<90
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Severe Respiratory Depression
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At 2hrs or at the time of discharge from PACUUse of rescue drug for pain
Outcome measures
| Measure |
Morphine
n=194 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Patients Requesting Oral Analgesia in the Day Surgery Unit
|
128 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: 5 hours post-admit to hospitalFor a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Mean Dose of Analgesic Used
|
5.7 Equivalent morphine unit
Standard Deviation 3.9
|
4.9 Equivalent morphine unit
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: At 5 hours post-admit to hospitalPatient satisfaction is measured on a 0-10 visual analogue scale, where 0=completely unsatisfied; 10=extremely satisfied
Outcome measures
| Measure |
Morphine
n=184 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=177 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Patient Satisfaction Score
|
9.1 score on a scale
Standard Deviation 1.8
|
9.3 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: At 2hrs or at the time of discharge from PACUFor a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours.
Outcome measures
| Measure |
Morphine
n=198 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=201 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Time to Discharge From PACU
|
91.2 Minutes
Standard Deviation 58.6
|
92.8 Minutes
Standard Deviation 50.6
|
SECONDARY outcome
Timeframe: At 5 hours post-admit to hospitalFor a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours.
Outcome measures
| Measure |
Morphine
n=199 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=197 Participants
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Time to Discharge From Hospital
|
3.2 Hours
Standard Deviation 1.1
|
3.3 Hours
Standard Deviation 1.1
|
Adverse Events
Morphine
Serious events: 11 serious events
Other events: 7 other events
Deaths: 0 deaths
Hydromorphone
Serious events: 10 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Morphine
n=199 participants at risk
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 participants at risk
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
5.5%
11/199 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
5.0%
10/202 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
Other adverse events
| Measure |
Morphine
n=199 participants at risk
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Morphine: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
Hydromorphone
n=202 participants at risk
Analgesia with equipotent doses of Morphine and Hydromorphone will be administered in titrated doses. Doses are 1ml=1mg of morphine or 0.2 mg of hydromorphone. Potency ratio of 1:5 (M: HM).
0.05mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml)
Hydromorphone: Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Severe itching
|
1.0%
2/199 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
2.5%
5/202 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
|
Nervous system disorders
Severe sedation
|
2.5%
5/199 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
4.0%
8/202 • At 2 hours or at the time of discharge from PACU, and at 24 h after surgery
|
Additional Information
Dr. Thuvaraha Vanniyasingam
Department of Anesthesia, McMaster University, Canada
Phone: (905) 525-9140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place