Phase 2
Completed N=298
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Source: ClinicalTrials.gov NCT00305110 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants Requiring Naloxone — 0 Participants
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
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 | — |
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
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. Informational only — not medical advice.