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

This study has been completed.

Study NCT00385541 Information provided by Columbia University

First Received on October 5, 2006. Last Updated on January 12, 2011 History of Changes

Results First Received: July 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Post Operative Pain
Interventions:	Drug: Morphine PCA Drug: Hydromorphone PCA

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Morphine PCA	Hydromorphone PCA
STARTED	25	25
COMPLETED	25	24
NOT COMPLETED	0	1
severe pain, clinician requested unblind	0	1

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Morphine PCA	Hydromorphone PCA	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	25	25	50
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	42 ± 12	44 ± 8	42.6 ± 10
Gender [units: participants]
Female	23	22	45
Male	2	3	5
Region of Enrollment [units: participants]
United States	25	25	50

Outcome Measures

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1. Primary:

Nausea Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

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2. Secondary:

Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

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3. Secondary:

Pain Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

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4. Secondary:

The Number of Patients Who Vomited [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

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5. Secondary:

Mean Score on the Ramsey Scale of Sedation [ Time Frame: 1 hour after surgery, 8 hours after surgery ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a small study under typical clinical conditions.

Results Point of Contact:

Name/Title: Pamela Flood MD
Organization: Columbia University
phone: 201-768-8262
e-mail: pdf3@columbia.edu

Publications of Results:

Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9.

Responsible Party:	Pamela Flood MD, Columbia University
ClinicalTrials.gov Identifier:	NCT00385541 History of Changes
Other Study ID Numbers:	AAAA2949(Y3M01)
Study First Received:	October 5, 2006
Results First Received:	July 14, 2010
Last Updated:	January 12, 2011
Health Authority:	United States: Institutional Review Board