Comparison of Side Effects of Morphine and Hydromorphone PCA - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00385541

Purpose

Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at our institution that hydromorphone causes less side effects but this has not been studied. We propose to treat our patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug

Condition	Intervention	Phase
Post Operative Pain Post Operative Side Effects of Narcotic Pain Medications	Drug: Morphine PCA Drug: Hydromorphone PCA	Phase IV

MedlinePlus related topics: Itching Nausea and Vomiting

Drug Information available for: Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Comparison of Morphine and Hydromorphone PCA

Further study details as provided by Columbia University:

Primary Outcome Measures:

Nausea [ Time Frame: 8 hours after surgery ]

Secondary Outcome Measures:

Pruritis, pain report NRS, vomiting, sedation [ Time Frame: 8 hours after surgery ]

Enrollment:	50
Study Start Date:	November 2003
Study Completion Date:	October 2007

Arms	Assigned Interventions
A: Active Comparator Patients receive morphine 1mg/ml as pca after surgery	Drug: Morphine PCA Morphine 1mg/ml, dose 1ml, lockout 6 minutes, max 10ml Drug: Hydromorphone PCA hydromorphone PCA 0.2mglml, dose 1ml, lockout 6min, max 10ml

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (BMI > 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385541

Locations

United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Pamela Flood, MD

Columbia University Medical Center

More Information

No publications provided

Study ID Numbers:	AAAA2949(Y3M01)
Study First Received:	October 5, 2006
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00385541 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

pain
morphine
hydromorphone

nausea
vomiting
pruritis

Study placed in the following topic categories:

Pruritus
Hydromorphone
Morphine
Vomiting
Central Nervous System Depressants
Narcotics
Pain

Signs and Symptoms
Postoperative Complications
Nausea
Analgesics
Peripheral Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

Additional relevant MeSH terms:

Hydromorphone
Morphine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 06, 2009