Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

NCT00305058 | Completed Phase 2 Results

• 1 other identifier: MMC 04-08-225E
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine which opiate pain medication (morphine or hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients presenting to the emergency department.

Conditions

Acute Pain

Keywords

Elderly; Hydromorphone; Morphine; Pain; Acute; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused

  Baseline to 30 minutes after medication infused

Secondary Outcomes (3)

• Number of Participants With a Change in Pain Score

  Baseline to 30 minutes after medication infused

• Number of Participants With Pain Relief

  30 minutes after medication infused

• Number of Participants Satisfied With Pain Medication

  30 minutes after medication infused

Study Arms (2)

Hydromorphone

EXPERIMENTAL

0.0075 mg/kg IV hydromorphone

Drug: Hydromorphone

Morphine

ACTIVE COMPARATOR

0.05 mg/kg IV morphine

Drug: Morphine

Interventions

Morphine DRUG

0.05 mg/kg Intravenous

Morphine

Hydromorphone DRUG

0.0075 mg/kg intravenous

Also known as: Dilaudid

Hydromorphone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age greater than 65 years
• Pain with onset within 7 days
• ED attending physician's judgment that patient's pain warrants use of parenteral opioids
• Normal mental status

You may not qualify if:

• Prior use of methadone
• Use of other opioids or tramadol within past seven days
• Prior adverse reaction to morphine or hydromorphone
• Chronic pain syndrome
• Alcohol intoxication
• Systolic Blood Pressure \<90 mm Hg
• Use of monoamine oxidase (MAO) inhibitors in past 30 days
• Elderly patients with a capnometry reading of greater than 46

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain; Emergencies

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Andrew Chang, MD
• Organization: Montefiore Medical Center

achang3@yahoo.com

718-920-6626

Study Officials

• Andrew K Chang, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 21, 2006
• Study Start: July 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-08

Locations

US (1)