Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain

Pain Conditions Clinical Trial

Official title:

Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789500
• Other study ID #: 2011-445
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: August 2012

Study information

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

Clinical Trial Summary

Current study is investigate the association between total body weight, body mass index and the clinical response to a fixed dose of intravenous hydromorphone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years of age English or Spanish speaking presenting to the ED with pain of less than or equal to 7 days' duration judged by the ED attending physicians to require intravenous opioid analgesics

Exclusion Criteria:

• inability or unwillingness to provide informed consent previous allergic reaction to hydromorphone systolic blood pressure less than 90 mmHg room air oxygen saturation by pulse oximetry < 95% at baseline alcohol or drug intoxication drug seeking behavior as judged by the attending physician use of other opioids or benzodiazepines within the past 24 hours use of a monoamine oxidase inhibitor in the past 30 days methadone use history of COPD, sleep apnea, renal failure, liver disease, or chronic pain syndrome (sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia) pregnancy or breast feeding and previous enrollment in the same study

Related Conditions & MeSH terms

• Acute Pain
• Pain Conditions

Intervention

Drug:
• Hydromorphone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jacobi Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain numerical rating scale change	pain intensity was measured based on numerical rating scale, 0 -10, with 0 as no pain and 10 as the worst pain intensity	30 minutes