Phase 4
N=50
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Post Operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00385541 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Nausea Assessment by Patient — 4.6; 3.0 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine PCA (Drug); Hydromorphone PCA (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea Assessment by Patient |
4.6; 3.0 | — |
| SECONDARY Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale |
2; 2.5 | — |
| SECONDARY Pain Assessment by Patient |
7.9; 7.1 | — |
| SECONDARY The Number of Patients Who Vomited |
1; 0 | — |
| SECONDARY Mean Score on the Ramsey Scale of Sedation |
2.8; 2.8 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00385541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.