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Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

NCT01311895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-05-18

Study results available
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Summary

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.

Conditions

  • Acute Pain

Interventions

DRUG

H2O

2 mg IV hydromorphone

DRUG

1+1

1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311895 on ClinicalTrials.gov