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

This study has been completed.
Information provided by:
Columbia University Identifier:
First received: October 5, 2006
Last updated: March 3, 2015
Last verified: March 2015
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
  • Mean Score on the Ramsey Scale of Sedation [ Time Frame: 1 hour after surgery, 8 hours after surgery ]
    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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00385541

United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Pamela Flood, MD Columbia University
  More Information

Responsible Party: Pamela Flood MD, Columbia University Identifier: NCT00385541     History of Changes
Other Study ID Numbers: AAAA2949
Study First Received: October 5, 2006
Results First Received: July 14, 2010
Last Updated: March 3, 2015

Keywords provided by Columbia University:

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 21, 2017