Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety
| Autor: | Shachar Shimonovich, Pinchas Halpern, Tal Sarig-Meth, Danielle Nadav, Amir Shapira, Debra West, Mattan Rozenek, Roy Gigi |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Adolescent Visual analogue scale Analgesic Pain Trauma law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method law Medicine Intranasal Ketamine Humans Ketamine 030212 general & internal medicine Prospective Studies Adverse effect Administration Intranasal Aged Pain Measurement Analgesics Morphine business.industry 030208 emergency & critical care medicine Middle Aged Clinical trial Intranasal ketamine Anesthesia Emergency Medicine Mass casualty Female Analgesia business Emergency Service Hospital medicine.drug Research Article |
| Zdroj: | BMC Emergency Medicine |
| ISSN: | 1471-227X |
| Popis: | Background Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. Methods A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18–70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by “time-to-onset” (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. Results The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. Conclusions IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Trial registration Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477 Electronic supplementary material The online version of this article (doi:10.1186/s12873-016-0107-0) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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