Safety and Efficacy Study of Hydromorphone and Morphine

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195910
• Other study ID #: MMC-04-08-225
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: January 2005

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Morphine
0.1 mg/kg IV morphine
• Hydromorphone
0.015 mg/kg IV hydromorphone

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity from baseline to 30 minutes after medications were infused.	Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)	baseline to 30 minutes after medication infused
Secondary	Pain intensity 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).	5 minutes after medication is given
Secondary	Pain intensity 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).	30 minutes after medication is given
Secondary	Pain intensity 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).	2 hours after medication is given
Secondary	Number of participants experiencing vomiting between 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	baseline to 5 minutes after medication is given
Secondary	Number of participants experiencing vomiting between 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 minutes after medication is given to 30 minutes after medication is given
Secondary	Number of participants experiencing vomiting between 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	31 minutes after medication is given to 120 minutes after medication is given
Secondary	Number of participants who received additional pain medication between baseline and 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	baseline to 5 minutes after medication was infused
Secondary	Number of participants who received additional pain medication between 6 and 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	6 minutes to 30 minutes after medication was infused
Secondary	Number of participants who received additional pain medication between 31 and 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	31 minutes to 120 minutes after medication was infused