Clinical trial · Interventional
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain
NCT00305110CI-TRIAL-00034446completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2 mg IV hydromorphone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2 mg IV hydromorphone
- description
- 2 mg IV hydromorphone administered over 2-3 minutes
- interventionNames
- Drug: 2 mg IV hydromorphone
Primary outcomes (1)
- measure
- Number of Participants Requiring Naloxone
- timeFrame
- immediately after infusion, up to 120 minutes post infusion
- description
- Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than 21 years 2. Age less than 65 years of age 3. Pain with onset within 7 days 4. ED attending physician's judgment that patient's pain warrants use of morphine 5. Normal mental status Exclusion Criteria: 1. Prior use of methadone 2. Use of other opioids or tramadol within past seven days 3. Prior adverse reaction to hydromorphone. 4. Chronic pain syndrome 5. Alcohol intoxication 6. SBP \<90 mm Hg 7. Use of MAO inhibitors in past 30 days 8. C02 measurement greater than 46
References
Publications (0)
Data not yet available
No reference posted for this study.