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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.

Group Type ACTIVE_COMPARATOR

Morphine PCA

Intervention Type DRUG

Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

B

Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.

Group Type ACTIVE_COMPARATOR

Hydromorphone PCA

Intervention Type DRUG

hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Interventions

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Morphine PCA

Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

Intervention Type DRUG

Hydromorphone PCA

hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Intervention Type DRUG

Other Intervention Names

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Astramorph PF Duramorph Infumorph Dilaudid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No