Safety and Efficacy Study of Hydromorphone and Morphine

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Morphine; Drug: Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT00195910

MMC-04-08-225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Morphine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

Hydromorphone

Experimental group

Description:

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

Treatment:

Drug: Hydromorphone