Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial

Introduction: Emergence agitation (EA) occurs shortly after emergence from anesthesia in pediatric patients causing disorientation, restlessness, and non-purposeful movement. This study aimed to compare intranasal dexmedetomidine (DEX) and oral midazolam in managing EA in pediatric patients schedul...

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Main Authors: Nastaran Sadat Mahdavi, Fatemeh Jafari, Farnaz Shahabi Shojaei, Seyed Sajjad Razavi, Morteza Mortazavi, Ali Reza Mahdavi
Format: Article
Language:English
Published: Shahid Beheshti University of Medical Sciences 2025-07-01
Series:Archives of Academic Emergency Medicine
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Online Access:https://journals.sbmu.ac.ir/aaem/index.php/AAEM/article/view/2797
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author Nastaran Sadat Mahdavi
Fatemeh Jafari
Farnaz Shahabi Shojaei
Seyed Sajjad Razavi
Morteza Mortazavi
Ali Reza Mahdavi
author_facet Nastaran Sadat Mahdavi
Fatemeh Jafari
Farnaz Shahabi Shojaei
Seyed Sajjad Razavi
Morteza Mortazavi
Ali Reza Mahdavi
author_sort Nastaran Sadat Mahdavi
collection DOAJ
description Introduction: Emergence agitation (EA) occurs shortly after emergence from anesthesia in pediatric patients causing disorientation, restlessness, and non-purposeful movement. This study aimed to compare intranasal dexmedetomidine (DEX) and oral midazolam in managing EA in pediatric patients scheduled for neurosurgical procedures. Methods: This double-blinded randomized clinical trial was conducted on 50 pediatric patients who underwent neurosurgical procedure in an educational hospital between March and June 2024. One group received intranasal DEX (2 mcg/kg) and other group received oral midazolam (1 mg/kg of midazolam) before induction of anesthesia. The rate of EA as well as vital signs changes were compared between the two groups using statistical analysis. Results: 50 participants were enrolled in the study and randomly divided to DEX and midazolam groups (25 participants in each group). The two groups were similar regarding age (p = 0.538); sex (p = 0.417); pre-operation heart rate (p = 0.675); systolic (p = 0.226) and diastolic (p = 0.753) blood pressure; and pre-operative mean arterial blood pressure (p = 0.634). Among all participants, 13 (26.00%) patients showed signs of EA after extubation (2 patients (8.00%) in DEX group and 11 (44.00%) patients in midazolam group; p = 0.004). Regrading vital signs, only the decrease in heart rate after extubation in the DEX group was significantly greater than that observed in the midazolam group (-9.28±12.88 vs. -2.48±8.23, respectively; p = 0.0310). The number needed to treat (NNT), relative risk reduction (RRR), and absolute risk reduction (ARR) of using intranasal DEX in management of EA were 2.77 (95%confidence interval (CI): 1.72-7.19), 81.8% (95%CI: 26.0%-95.5%), and 36.0% (95%CI: 13.9%-58.1%) respectively. Conclusion: Intranasal DEX compare to oral midazolam demonstrated superior efficacy in managing postoperative EA in pediatric patients.
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spelling doaj-art-f153d203292d47f4b04eaee8bbefaf4d2025-08-20T04:00:56ZengShahid Beheshti University of Medical SciencesArchives of Academic Emergency Medicine2645-49042025-07-0113110.22037/aaemj.v13i1.2797Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical TrialNastaran Sadat Mahdavi0Fatemeh JafariFarnaz Shahabi Shojaei1Seyed Sajjad Razavi2Morteza Mortazavi3Ali Reza Mahdavi4Department of Anesthesiology, School of Medicine, Mofid Children's Hospital, Shahid Beheshti University of Medical SciencesDepartment of Anesthesiology, School of Medicine, Mofid Children's Hospital, Shahid Beheshti University of Medical SciencesDepartment of Anesthesiology, School of Medicine, Mofid Children's Hospital, Shahid Beheshti University of Medical SciencesResident of Anesthesiology, Shahid Beheshti University of Medical Science, Tehran, IranDepartment of Anesthesiology, School of Medicine, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences Introduction: Emergence agitation (EA) occurs shortly after emergence from anesthesia in pediatric patients causing disorientation, restlessness, and non-purposeful movement. This study aimed to compare intranasal dexmedetomidine (DEX) and oral midazolam in managing EA in pediatric patients scheduled for neurosurgical procedures. Methods: This double-blinded randomized clinical trial was conducted on 50 pediatric patients who underwent neurosurgical procedure in an educational hospital between March and June 2024. One group received intranasal DEX (2 mcg/kg) and other group received oral midazolam (1 mg/kg of midazolam) before induction of anesthesia. The rate of EA as well as vital signs changes were compared between the two groups using statistical analysis. Results: 50 participants were enrolled in the study and randomly divided to DEX and midazolam groups (25 participants in each group). The two groups were similar regarding age (p = 0.538); sex (p = 0.417); pre-operation heart rate (p = 0.675); systolic (p = 0.226) and diastolic (p = 0.753) blood pressure; and pre-operative mean arterial blood pressure (p = 0.634). Among all participants, 13 (26.00%) patients showed signs of EA after extubation (2 patients (8.00%) in DEX group and 11 (44.00%) patients in midazolam group; p = 0.004). Regrading vital signs, only the decrease in heart rate after extubation in the DEX group was significantly greater than that observed in the midazolam group (-9.28±12.88 vs. -2.48±8.23, respectively; p = 0.0310). The number needed to treat (NNT), relative risk reduction (RRR), and absolute risk reduction (ARR) of using intranasal DEX in management of EA were 2.77 (95%confidence interval (CI): 1.72-7.19), 81.8% (95%CI: 26.0%-95.5%), and 36.0% (95%CI: 13.9%-58.1%) respectively. Conclusion: Intranasal DEX compare to oral midazolam demonstrated superior efficacy in managing postoperative EA in pediatric patients. https://journals.sbmu.ac.ir/aaem/index.php/AAEM/article/view/2797DexmedetomidineMidazolamAnesthesiaPediatricAgitationNeurosurgery
spellingShingle Nastaran Sadat Mahdavi
Fatemeh Jafari
Farnaz Shahabi Shojaei
Seyed Sajjad Razavi
Morteza Mortazavi
Ali Reza Mahdavi
Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
Archives of Academic Emergency Medicine
Dexmedetomidine
Midazolam
Anesthesia
Pediatric
Agitation
Neurosurgery
title Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
title_full Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
title_fullStr Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
title_full_unstemmed Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
title_short Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
title_sort intranasal dexmedetomidine vs oral midazolam in pediatric emergence agitation management following anesthesia a double blind randomized clinical trial
topic Dexmedetomidine
Midazolam
Anesthesia
Pediatric
Agitation
Neurosurgery
url https://journals.sbmu.ac.ir/aaem/index.php/AAEM/article/view/2797
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