A Trial Comparing Different Dosing Regimens of Morphine in Patients With Moderate to Severe Pain

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00293969
First received: February 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the difference in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?

HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.

SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.


Condition Intervention
Pain
Drug: Morphine 0.1mg/kg versus morphine 0.15 mg/kg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Different Dosing Regimens of Intravenous Morphine in the Treatment of Adult Patients Presenting to the Emergency Department With Moderate to Severe Pain

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • The between-group difference in mean before-after difference in pain score at baseline and 60 minutes in patients randomized to receive either 0.10 mg/kg or 0.15 mg/kg morphine

Secondary Outcome Measures:
  • Between-group comparison of mean change in pain score from 30 min to 60 min
  • Comparison of between-group differences in pain relief scores
  • Patient satisfaction score
  • Adverse events at 30 and 60 minutes
  • Number of additional boluses of analgesics needed within 60 minutes for the two groups.
  • NRS pain score percent reduction at 60 min calculated as NRS pain score reduction from baseline to 60 min divided by baseline NRS score

Estimated Enrollment: 280
Study Start Date: March 2005
Estimated Study Completion Date: January 2006
Detailed Description:

RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to administer intravenous opiates, what is the between-group difference in before-after improvement in pain relief at 60 minutes in patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?

HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.

SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may be able to provide evidence to suggest that the higher dose should be used for adult ED patients under the age of 66 presenting with acute pain.

METHODS/DESIGN: Prospective, double blind, randomized clinical trial. Adult ED patients between the ages of 18 and 65 years of age in whom the attending ED physician has decided to administer parenteral opiates, will be randomized to receive either 0.1 mg/kg IV morphine (maximum dose of 10 mg) or 0.15mg/kg IV morphine (maximum dose of 15 mg). An on-line random plan generator (http://www.randomization.com) will be used to generate an allocation schedule. The allocation schedule will be fully documented with the reference citation of the pseudo-random number generator, the seed used to start the generation process, the number of treatments (2), the allocation ratio (1:1), the size and number of blocks, and a copy of the assignment list. The allocation schedule will be given to the Montefiore Department of Pharmacy where it will be used to determine the content of consecutively numbered vials with either the study doses of morphine. The Pharmacy Department will prepare and handle the vials in accordance with known stability data and labeled with expiration dates. They will provide the study with labeled packages containing the numbered vial, a label with the vial number to be attached to the patient’s data collection instrument, an opaque envelope with the assignment group identified (to be used in the event of a clinical emergency that requires immediate determination of what the patient received) and a weight based dosing schedule for morphine. All patients will receive a bolus of morphine 0.1mg/kg at time 0. At 30 minutes, patients will receive the study drug which will contain either an additional 0.05mg/kg of morphine or placebo. After the initial morphine bolus and study drug, patients will have received either morphine 0.1 mg/kg (maximum of 10 mg) or 0.15 mg/kg (maximum of 15mg).

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients 21 to 65 years of age presenting to the ED with pain of less than or equal to 7 days duration and deemed by the ED attending to require opioid analgesia are eligible for inclusion.

Exclusion Criteria:

Inability or unwillingness to provide informed consent, methadone use, use of other opioids or tramadol within 7 days, prior adverse reaction to morphine, chronic pain syndrome, alcohol intoxication, pregnancy or breast-feeding, systolic blood pressure <90 mm Hg, use of MAO inhibitors, and weight greater than 100 kg.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00293969

Locations
United States, New York
Montefiore Medical Center Emergency Department
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Adrienne J. Birnbaum, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293969     History of Changes
Other Study ID Numbers: 04-12-360
Study First Received: February 17, 2006
Last Updated: February 17, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Pain
Morphine

Additional relevant MeSH terms:
Morphine
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 August 21, 2014