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

July 16, 2018 updated by: Pamela Flood, Columbia University

The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Other Names:
  • Infumorph
  • Duramorph
  • Astramorph PF
Active Comparator: B
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Other Names:
  • Dilaudid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 9, 2006

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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