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

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Hydromorphone PCA; Drug: Morphine PCA

• Registration Number: NCT00385541
• Lead Sponsor: Columbia University

Brief Summary

Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2010-07-14
• Results First Submitted QC: 2010-08-11
• Results First Posted: 2010-08-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients scheduled for abdominal surgery requiring post-operative PCA
• ASA = I or II

Exclusion Criteria

• preoperative pain or use of pain medication
• narcotic allergy
• morbid obesity (Body Mass Index > 30)
• diagnosis of sleep apnea
• hepatic or renal disease
• use of medications that would affect narcotic pharmacodynamics
• preoperative nausea, vomiting, or pruritis
• diagnosis of alcoholism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Hydromorphone PCA	Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
A	Morphine PCA	Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.

Primary Outcome Measures

Name	Time	Method
Nausea Assessment by Patient	1 hour after surgery, 8 hours after surgery	Nausea scale range: (0 = none, 10 = the worst), ordinal.

Secondary Outcome Measures

Name	Time	Method
Pain Assessment by Patient	1 hour after surgery, 8 hours after surgery	Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale	1 hour after surgery, 8 hours after surgery	The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).
The Number of Patients Who Vomited	1 hour after surgery, 8 hours after surgery
Mean Score on the Ramsey Scale of Sedation	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).

Trial Locations

Locations (1)

Columbia Presbyterian Hospital; 🇺🇸 New York, New York, United States