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      Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety

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          Abstract

          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.

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          Most cited references25

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          Effect of subanesthetic ketamine on intrinsic functional brain connectivity: a placebo-controlled functional magnetic resonance imaging study in healthy male volunteers.

          Marieke Niesters, Najmeh Khalili-Mahani, Christian Martini … (2012)
          The influence of psychoactive drugs on the central nervous system has been investigated with positron emission tomography and task-related functional magnetic resonance imaging. However, it is not known how these drugs affect the intrinsic large-scale interactions of the brain (resting-state functional magnetic resonance imaging connectivity). In this study, the effect of low-dose S(+)-ketamine on intrinsic brain connectivity was investigated.
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            Determining the minimum clinically significant difference in visual analog pain score for children.

            Lydia Powell, Jennifer A Williams, Matthew S. Kelly (2000)
            We sought to determine the minimum clinically significant difference in visual analog scale (VAS) pain score for children. We performed a prospective, single-group, repeated-measures study of children between 8 and 15 years presenting to an urban pediatric emergency department with acute pain. On presentation to the ED, patients marked the level of their pain on a 100-mm nonhatched VAS scale. At 20-minute intervals thereafter, they were asked to give a verbal categoric rating of their pain as "heaps better," "a bit better," "much the same," "a bit worse," or "heaps worse" and to mark the level of pain on a VAS scale of the same type as used previously. A maximum of 3 comparisons was recorded for each child. The minimum clinically significant difference in VAS pain score was defined as the mean difference between current and preceding scores when the subject reported "a bit worse" or "a bit better" pain. Seventy-three children were enrolled in the study, yielding 103 evaluable comparisons in which pain was rated as "a bit better" or "a bit worse." The minimum clinically significant difference in VAS score was 10 mm (95% confidence interval 7 to 12 mm). This study found the minimum clinically significant difference in VAS pain score for children aged 8 to 15 years (on a 100-mm VAS scale) to be 10 mm (95% confidence interval 7 to 12 mm). In studies of populations, differences of less than this amount, even if statistically significant, are unlikely to be of clinical significance.
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              Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil.

              Aurélie Bourgoin, Renaud Vialet, Nicolas Wereszczynski … (2003)
              The aim of the study was to compare the safety concerning cerebral hemodynamics of ketamine and sufentanil used for sedation of severe head injury patients, both drugs being used in combination with midazolam. Prospective, randomized, double-blind study. Intensive care unit in a trauma center. Twenty-five patients with severe head injury. Twelve patients received sedation with a continuous infusion of ketamine-midazolam and 13 with a continuous infusion of sufentanil-midazolam. All patients were mechanically ventilated with moderate hyperventilation. Prognostic indicators (age, Glasgow Coma Scale scores, computed tomography diagnosis, and Injury Severity Scale score) were similar in the two groups at study entry. Measurements were carried out during the first 4 days of sedation. The average infusion rates during this time were 82 +/- 25 micro x kg x min ketamine and 1.64 +/- 0.5 microg x kg x min midazolam in the ketamine group and 0.008 +/- 0.002 microg x kg x min sufentanil and 1.63 +/- 0.37 microg x kg x min midazolam in the sufentanil group. No significant differences were observed between the two groups in the mean daily values of intracranial pressure and cerebral perfusion pressure. The numbers of intracranial pressure elevations were similar in both groups. The requirements of neuromuscular blocking agents, propofol, and thiopental were similar. Heart rate values were significantly higher in the ketamine group on therapy days 3 and 4 ( <.05). With regard to arterial pressure control, more fluids were given on the first therapy day and there was a trend toward greater use of vasopressors in the sufentanil group. Sedative costs were similar in the two groups. The results of this study suggest that ketamine in combination with midazolam is comparable with a combination of midazolam-sufentanil in maintaining intracranial pressure and cerebral perfusion pressure of severe head injury patients placed under controlled mechanical ventilation.
              Article 0 comments Cited 48 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Shachar Shimonovich: shachar.shimonovich@gmail.com
                Roy Gigi: roygigimd@gmail.com
                Amir Shapira: amirshapira@gmail.com
                Tal Sarig-Meth: talimeth@gmail.com
                Danielle Nadav: dnadav929@gmail.com
                Mattan Rozenek: mattanrozenek1@gmail.com
                Debra West: debraw@tlvmc.gov.il
                Pinchas Halpern: +972-3-6973829 , dr_halperin@tlvmc.gov.il , http://www.tasmc.org.il/sites/en/surgery/ER/Pages/ER.aspx
                Journal
                Journal ID (nlm-ta): BMC Emerg Med
                Journal ID (iso-abbrev): BMC Emerg Med
                Title: BMC Emergency Medicine
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-227X
                Publication date (Electronic): 9 November 2016
                Publication date PMC-release: 9 November 2016
                Publication date Collection: 2016
                Volume: 16
                Electronic Location Identifier: 43
                Affiliations
                [1 ]Sackler School of Medicine at Tel Aviv University, 55 Haim Levanon Street, Ramat Aviv, 69978 Israel
                [2 ]Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv, 64239 Israel
                [3 ]Department of Emergency Medicine, Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv, 64239 Israel
                Article
                Publisher ID: 107
                DOI: 10.1186/s12873-016-0107-0
                PMC ID: 5103427
                PubMed ID: 27829367
                SO-VID: 5154b787-e2e2-4ad3-8dc3-3e54dea9d96e
                Copyright © © The Author(s). 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 16 July 2016
                Date accepted : 2 November 2016
                Funding
                Funded by: IDF Medical Corps
                Award ID: 22509
                Award Recipient :
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Emergency medicine & Trauma
                Keywords: intranasal ketamine,analgesia,trauma,morphine,mass casualty
                Data availability:
                ScienceOpen disciplines: Emergency medicine & Trauma
                Keywords: intranasal ketamine, analgesia, trauma, morphine, mass casualty

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