Trial Outcomes & Findings for Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA) (NCT NCT00385541)

NCT ID: NCT00385541

Last Updated: 2018-08-14

Results Overview

Nausea scale range: (0 = none, 10 = the worst), ordinal.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 hour after surgery, 8 hours after surgery
• Results posted on: 2018-08-14

Participant Flow

Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone

Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.

Participant milestones

Measure	Morphine PCA Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Overall Study STARTED	25	25
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Morphine PCA Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Overall Study severe pain, clinician requested unblind	0	1

Baseline Characteristics

Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Baseline characteristics by cohort

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 12 • n=5 Participants	44 years STANDARD_DEVIATION 8 • n=7 Participants	42.6 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour after surgery, 8 hours after surgery

Population: Intention to treat (ITT)

Nausea scale range: (0 = none, 10 = the worst), ordinal.

Outcome measures

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Nausea Assessment by Patient	4.6 Units on a scale Standard Deviation 3.2	3.0 Units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 hour after surgery, 8 hours after surgery

The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).

Outcome measures

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale	2 Units on a scale Standard Deviation 0	2.5 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 1 hour after surgery, 8 hours after surgery

Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.

Outcome measures

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Pain Assessment by Patient	7.9 Units on a scale Standard Deviation 2.3	7.1 Units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 1 hour after surgery, 8 hours after surgery

Outcome measures

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
The Number of Patients Who Vomited	1 participants	0 participants

SECONDARY outcome

Timeframe: 1 hour after surgery, 8 hours after surgery

The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).

Outcome measures

Measure	Morphine PCA n=25 Participants Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes	Hydromorphone PCA n=25 Participants Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
Mean Score on the Ramsey Scale of Sedation	2.8 score on scale Standard Deviation 0.6	2.8 score on scale Standard Deviation 0.7

Adverse Events

Morphine PCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hydromorphone PCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pamela Flood

Columbia University

Phone: 201-370-3933

Email: pflood@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place