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

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00385541
First received: October 5, 2006
Last updated: January 12, 2011
Last verified: January 2011
  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
Drug: Morphine PCA
Drug: Hydromorphone PCA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Nausea Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ]
    Nausea scale range: (0 = none, 10 = the worst), ordinal.


Secondary Outcome Measures:
  • Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ]
    The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).

  • Pain Assessment by Patient [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ]
    Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.

  • The Number of Patients Who Vomited [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ]
  • Mean Score on the Ramsey Scale of Sedation [ Time Frame: 1 hour after surgery, 8 hours after surgery ] [ Designated as safety issue: No ]
    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).


Enrollment: 50
Study Start Date: November 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
Drug: Morphine PCA
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Other Names:
  • Astramorph PF
  • Duramorph
  • Infumorph
Active Comparator: B
Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
Drug: Hydromorphone PCA
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
Other Name: Dilaudid

Detailed Description:

Patients having general surgery at Columbia University Medical Center that will require Patient-Controlled Analgesia Inclusion: 18-60. American Society of Anesthesiologists (ASA) 1-2 Exclusion, pregnancy, lactation, chronic pain or opioids prior to surgery

  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 (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
  Contacts and Locations
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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
  More Information

Publications:
Responsible Party: Pamela Flood MD, Columbia University
ClinicalTrials.gov Identifier: NCT00385541     History of Changes
Other Study ID Numbers: AAAA2949(Y3M01)
Study First Received: October 5, 2006
Results First Received: July 14, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
pain
morphine
hydromorphone
nausea
vomiting
pruritis

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014