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

Post Operative Pain Clinical Trial

Official title:

The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385541
• Other study ID #: AAAA2949
• Status: Completed
• Phase: Phase 4
• Start date: November 2003
• Est. completion date: October 2007

Study information

• Verified date: July 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Morphine PCA
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
• Hydromorphone PCA
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Locations

Country	Name	City	State
United States	Columbia Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea Assessment by Patient	Nausea scale range: (0 = none, 10 = the worst), ordinal.	1 hour after surgery, 8 hours after surgery
Secondary	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
Secondary	Pain Assessment by Patient	Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.	1 hour after surgery, 8 hours after surgery
Secondary	The Number of Patients Who Vomited		1 hour after surgery, 8 hours after surgery
Secondary	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