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

Study Overview
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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

Official Title
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The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Morphine PCA
* Drug: Hydromorphone PCA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. | Drug: Morphine PCA<br>* Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL<br>* Other names: Infumorph;|
| Active Comparator: B<br>Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes. | Drug: Hydromorphone PCA<br>* hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml<br>* Other names: Dilaudid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Assessment by Patient | 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 | 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 | 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 |  | 1 hour after surgery, 8 hours after surgery | 
| Mean Score on the Ramsey Scale of Sedation | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, morphine, hydromorphone, nausea, vomiting, pruritis