Safety and Efficacy Study of Hydromorphone and Morphine

NCT ID: NCT00195910

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-01-31

Brief Summary

To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.

Detailed Description

There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Morphine

single dose of intravenous (IV) morphine, 0.1 mg/kg

intervention: 0.1 mg/kg IV morphine

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

0.1 mg/kg IV morphine

Hydromorphone

single dose of intravenous (IV) hydromorphone, 0.015 mg/kg

intervention: 0.015 mg/kg IV hydromorphone

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

0.015 mg/kg IV hydromorphone

Interventions

Morphine

0.1 mg/kg IV morphine

Intervention Type: DRUG

Hydromorphone

0.015 mg/kg IV hydromorphone

Intervention Type: DRUG

Other Intervention Names

Dilaudid

Eligibility Criteria

Inclusion Criteria

• adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.

Exclusion Criteria

• previous allergy to morphine or hydromorphone
• systolic blood pressure less than 90 mmHg
• alcohol intoxication as judged by the attending physician
• use of other opioids within the past 7 days
• use of an Monoamine Oxidase (MAO) inhibitor
• chronic pain syndromes (such as sickle cell disease or fibromyalgia)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrew Chang, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew K Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

MMC-04-08-225

Identifier Type: -

Identifier Source: org_study_id