Skip to main content
OpenTrials
Completed

NCT Number: NCT00195910

Safety and Efficacy Study of Hydromorphone and Morphine

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Morphine

Drug

0.1 mg/kg IV morphine

Hydromorphone

Drug

0.015 mg/kg IV hydromorphone

Other names: Dilaudid

Primary outcomes

  1. Change in Pain Intensity from baseline to 30 minutes after medications were infused.

    Time frame: baseline to 30 minutes after medication infused

    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)

Secondary outcomes

  1. Pain intensity 5 minutes after medication is given

    Time frame: 5 minutes after medication is given

    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  2. Pain intensity 30 minutes after medication is given

    Time frame: 30 minutes after medication is given

    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  3. Pain intensity 2 hours after medication is given

    Time frame: 2 hours after medication is given

    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  4. Number of participants experiencing vomiting between baseline to 5 minutes after medication is given

    Time frame: baseline to 5 minutes after medication is given

    Number of participants who experienced vomiting and required medication between baseline and 5 minutes after medication was infused

  5. Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given

    Time frame: 6 minutes after medication is given to 30 minutes after medication is given

    Number of participants who experienced vomiting and required medication between 6 minutes after medication was infused and 30 minutes after medication was infused

  6. Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given

    Time frame: 31 minutes after medication is given to 120 minutes after medication is given

    Number of participants who experienced vomiting and required medication between 31 minutes after medication was infused and 120 minutes after medication was infused

  7. Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused

    Time frame: baseline to 5 minutes after medication was infused

    Number of participants for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between baseline and 5 minutes after medication was infused

  8. Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused

    Time frame: 6 minutes to 30 minutes after medication was infused

    Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 6 and 30 minutes after the medication was infused

  9. Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused

    Time frame: 31 minutes to 120 minutes after medication was infused

    Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 31 and 120 minutes after medication was infused

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.