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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00385541
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : August 31, 2010
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pamela Flood, Columbia University

Brief 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

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Morphine PCA Drug: Hydromorphone PCA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Actual Study Start Date : November 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.

  3. The Number of Patients Who Vomited [ Time Frame: 1 hour after surgery, 8 hours after surgery ]
  4. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385541


Locations
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United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Pamela Flood, MD Columbia University
Publications of Results:
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Responsible Party: Pamela Flood, Professor of Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT00385541    
Other Study ID Numbers: AAAA2949
First Posted: October 9, 2006    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: August 14, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pamela Flood, Columbia University:
pain
morphine
hydromorphone
nausea
vomiting
pruritis
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents