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Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial

Objective: To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department. Methods: Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7 mg/kg)...

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Autores principales: Rubinstein, Orit, Barkan, Shiri, Breitbart, Rachelle, Berkovitch, Sofia, Toledano, Michal, Weiser, Giora, Karadi, Natali, Nassi, Anat, Kozer, Eran
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4937914/
https://www.ncbi.nlm.nih.gov/pubmed/27368000
http://dx.doi.org/10.1097/MD.0000000000003984
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author Rubinstein, Orit
Barkan, Shiri
Breitbart, Rachelle
Berkovitch, Sofia
Toledano, Michal
Weiser, Giora
Karadi, Natali
Nassi, Anat
Kozer, Eran
author_facet Rubinstein, Orit
Barkan, Shiri
Breitbart, Rachelle
Berkovitch, Sofia
Toledano, Michal
Weiser, Giora
Karadi, Natali
Nassi, Anat
Kozer, Eran
author_sort Rubinstein, Orit
collection PubMed
description Objective: To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department. Methods: Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7 mg/kg) or with oral ketamine (5 mg/kg). Main outcomes measured were level of pain during local anesthesia, as assessed by the parent on a 10-cm visual analog scale (VAS) and the number of children who required intravenous sedation. Secondary outcomes included VAS by physician, pain assessment by child, maximal sedation depth assessed by the University of Michigan Sedation Scale, time until University of Michigan Sedation Scale 2 or more, general satisfaction of a parent and treating physician, length of procedure, total sedation time, and the incidence of any adverse events. Results: Sixty-eight children were recruited of which 33 were girls. Average age was 5.08 ± 2.14 years. Thirty-seven children were treated with ketamine and 31 with midazolam. Parent-assessed VAS in ketamine treated patients was 5.07 ± 0.75 compared with 3.68 ± 0.7 in midazolam treated patients [mean difference = 1.39 95% confidence interval (CI) –0.47 to 3.26]. Twelve (32%) of the children treated with ketamine required the addition of IV sedation compared to only 2 children (6%) of the children treated with midazolam [odds ratio (adjusted for age and gender) 6.1, 95% CI: 1.2 to 30.5]. The rest of the measured variables were similar between the groups, with no statistical significance. Discussion: No difference in the level of pain was found between ketamine and midazolam treated patients. Compared with oral midazolam (0.7 mg/kg), oral ketamine (5 mg/kg) was associated with higher rates of sedation failure, and thus is not recommended as a single agent for oral sedation in children requiring laceration repair.
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spelling pubmed-49379142016-08-18 Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial Rubinstein, Orit Barkan, Shiri Breitbart, Rachelle Berkovitch, Sofia Toledano, Michal Weiser, Giora Karadi, Natali Nassi, Anat Kozer, Eran Medicine (Baltimore) 6200 Objective: To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department. Methods: Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7 mg/kg) or with oral ketamine (5 mg/kg). Main outcomes measured were level of pain during local anesthesia, as assessed by the parent on a 10-cm visual analog scale (VAS) and the number of children who required intravenous sedation. Secondary outcomes included VAS by physician, pain assessment by child, maximal sedation depth assessed by the University of Michigan Sedation Scale, time until University of Michigan Sedation Scale 2 or more, general satisfaction of a parent and treating physician, length of procedure, total sedation time, and the incidence of any adverse events. Results: Sixty-eight children were recruited of which 33 were girls. Average age was 5.08 ± 2.14 years. Thirty-seven children were treated with ketamine and 31 with midazolam. Parent-assessed VAS in ketamine treated patients was 5.07 ± 0.75 compared with 3.68 ± 0.7 in midazolam treated patients [mean difference = 1.39 95% confidence interval (CI) –0.47 to 3.26]. Twelve (32%) of the children treated with ketamine required the addition of IV sedation compared to only 2 children (6%) of the children treated with midazolam [odds ratio (adjusted for age and gender) 6.1, 95% CI: 1.2 to 30.5]. The rest of the measured variables were similar between the groups, with no statistical significance. Discussion: No difference in the level of pain was found between ketamine and midazolam treated patients. Compared with oral midazolam (0.7 mg/kg), oral ketamine (5 mg/kg) was associated with higher rates of sedation failure, and thus is not recommended as a single agent for oral sedation in children requiring laceration repair. Wolters Kluwer Health 2016-07-01 /pmc/articles/PMC4937914/ /pubmed/27368000 http://dx.doi.org/10.1097/MD.0000000000003984 Text en Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0, where it is permissible to download, share and reproduce the work in any medium, provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0
spellingShingle 6200
Rubinstein, Orit
Barkan, Shiri
Breitbart, Rachelle
Berkovitch, Sofia
Toledano, Michal
Weiser, Giora
Karadi, Natali
Nassi, Anat
Kozer, Eran
Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title_full Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title_fullStr Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title_full_unstemmed Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title_short Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: A double-blind, randomized, controlled trial
title_sort efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair: a double-blind, randomized, controlled trial
topic 6200
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4937914/
https://www.ncbi.nlm.nih.gov/pubmed/27368000
http://dx.doi.org/10.1097/MD.0000000000003984
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