Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
Summary
Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED). The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED. The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates. The investigators also asses side effects and patient satisfaction in both groups.
Timeline
- Start
- 2013-08-02
- Primary completion
- 2016-04-10
- Completion
- 2016-06-30
Outcome
Met primary endpoint
paper the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. PMID 31310600 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 0.05 mg/kg | Intravenous |
| Comparator | Morphine | Other / unclassified | 0.1 mg/kg | Intravenous |
| Subject | Sufentanil | Other / unclassified | 0.15 ug/kg | Intranasal |
| Subject | Sufentanil | Other / unclassified | 0.3 ug/kg | Intranasal |
Indications
No indication recorded.