Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 5, 2006
January 12, 2011
November 2003
October 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00385541 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post Operative Pain
  • Drug: Morphine PCA
    Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
    Other Names:
    • Astramorph PF
    • Duramorph
    • Infumorph
  • Drug: Hydromorphone PCA
    hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
    Other Name: Dilaudid
  • Active Comparator: A
    Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.
    Intervention: Drug: Morphine PCA
  • Active Comparator: B
    Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
    Intervention: Drug: Hydromorphone PCA
Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385541
AAAA2949(Y3M01)
No
Pamela Flood MD, Columbia University
Columbia University
Not Provided
Principal Investigator: Pamela Flood, MD Columbia University
Columbia University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP