Phase 2 N=298 Treatment

Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain

Acute Pain

Bottom Line

View on ClinicalTrials.gov: NCT00305110 ↗

Enrolled (actual)

298

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Number of Participants Requiring Naloxone — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 2 mg IV hydromorphone (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Requiring Naloxone	—	—
SECONDARY Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute	12	—
SECONDARY Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg	2	—
SECONDARY Oxygen Desaturation Measured Over 2-hour Time Frame	68; 26; 6	—
SECONDARY Oxygen Saturation Measured Over 2-hour Time Frame	99; 98; 98; 98; 98; 97	—

Summary

The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain

Eligibility Criteria

Inclusion Criteria

Age greater than 21 years
Age less than 65 years of age
Pain with onset within 7 days
ED attending physician's judgment that patient's pain warrants use of morphine
Normal mental status

Exclusion Criteria

Prior use of methadone
Use of other opioids or tramadol within past seven days
Prior adverse reaction to hydromorphone.
Chronic pain syndrome
Alcohol intoxication
SBP <90 mm Hg
Use of MAO inhibitors in past 30 days
C02 measurement greater than 46

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00305110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.