Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial
学术急诊医学档案,
卷 13 编号 1 (2025),
6 六月 2025
,
第 e66 页
https://doi.org/10.22037/aaemj.v13i1.2797
摘要
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.
- Dexmedetomidine
- Midazolam
- Anesthesia
- Pediatric
- Agitation
- Neurosurgery
##submission.howToCite##
参考
Menser C, Smith H. Emergence agitation and delirium: considerations for epidemiology and routine monitoring in pediatric patients. Local Reg Anesth. 2020;13:73-83.
Eckenhoff JE, Kneale DH, Dripps RD. The incidence and etiology of postanesthetic excitement a clinical survey. Anesthesiology. 1961;22(5):667-73.
Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003;96(6):1625-30.
Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007;104(1):84-91.
Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, et al. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010;104(2):216-23.
Doerrfuss JI, Kramer S, Tafelski S, Spies CD, Wernecke K-D, Nachtigall I. Frequency, predictive factors and therapy of emergence delirium: data from a large observational clinical trial in a broad spectrum of postoperative pediatric patients. Minerva Anestesiol. 2019;85(6):617-24.
Lee S-J, Choi SJ, In CB, Sung T-Y. Effects of tramadol on emergence agitation after general anesthesia for nasal surgery: a retrospective cohort study. Medicine. 2019;98(10):e14763.
Jee YS, You H-J, Sung T-Y, Cho C-K. Effects of nefopam on emergence agitation after general anesthesia for nasal surgery: a prospective, randomized, and controlled trial. Medicine. 2017;96(47):e8843.
Aniley HT, Mekuria ST, Kebede MA, Gebreanania AH, Muleta MB, Aniley TT. Magnitude of emergence agitation, its interventions and associated factors among paediatric surgical patients. BMC Anesthesiol. 2024;24(1):236.
Mohkamkar M, Farhoudi F, Alam-Sahebpour A, Mousavi S-A, Khani S, Shahmohammadi S. Postanesthetic emergence agitation in pediatric patients under general anesthesia. Iran J Pediatr. 2014;24(2):184-90.
Urits I, Peck J, Giacomazzi S, Patel R, Wolf J, Mathew D, et al. Emergence delirium in perioperative pediatric care: a review of current evidence and new directions. Adv Ther. 2020;37:1897-909.
Mamuda A, Gudaji MI. Effect of oral midazolam in preventing postoperative emergence agitation in children. Sahel Med J. 2019;22(1):1-7.
Reynolds T, Sankaran S, Chimbira WT, Phan T, Nafiu OO. Severe obesity and sleep-disordered breathing as risk factors for emergence agitation in pediatric ambulatory surgery. J Perianesth Nurs. 2018;33(3):304-11.
Eshetie D, Getinet H, Abdissa Z, Mollalign M. Incidence and associated factors of emergence agitation after general anesthesia and surgery among pediatric patients: a prospective follow-up study. Int J Surg Open. 2020;27:25-31.
Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016;30:261-7.
Barends CR, Absalom A, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety. PLoS One. 2017;12(1):e0169525.
Zhang C, Li J, Zhao D, Wang Y. Prophylactic midazolam and clonidine for emergence from agitation in children after emergence from sevoflurane anesthesia: a meta-analysis. Clin Ther. 2013;35(10):1622-31.
Köner Ö, Türe H, Mercan A, Menda F, Sözübir S. Effects of hydroxyzine–midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011;28(9):640-5.
Peter J-U, Dieudonné P, Zolk O. Pharmacokinetics, pharmacodynamics, and side effects of midazolam: A review and case example. Pharmaceuticals. 2024;17(4):473.
Li L-Q, Wang C, Xu H-Y, Lu H-L, Zhang H-Z. Effects of different doses of intranasal dexmedetomidine on preoperative sedation and postoperative agitation in pediatric with total intravenous anesthesia undergoing adenoidectomy with or without tonsillectomy. Medicine. 2018;97(39):e12140.
Bilotta F, Pugliese F. The evolving clinical use of dexmedetomidine. Lancet. 2020;396(10245):145-7.
Lin Y, Zhang R, Shen W, Chen Q, Zhu Y, Li J, et al. Dexmedetomidine versus other sedatives for non-painful pediatric examinations: a systematic review and meta-analysis of randomized controlled trials. J Clin Anesth. 2020;62:109736.
Liu X, Li Y, Kang L, Wang Q. Recent advances in the clinical value and potential of dexmedetomidine. J Inflamm Res. 2021;14:7507-27.
Nair S, Wolf A. Emergence delirium after paediatric anaesthesia: new strategies in avoidance and treatment. BJA educ. 2018;18(1):30-3.
Lee S. Dexmedetomidine: present and future directions. Korean J Anesthesiol. 2019;72(4):323-30.
Taneja S, Jain A. Systematic review and meta-analysis comparing the efficacy of dexmedetomidine to midazolam as premedication and a sedative agent in pediatric patients undergoing dental procedures. Oral Maxillofac Surg. 2023;27(4):547-57.
Wen J, Ding X, Liu C, Jiang W, Xu Y, Wei X, et al. A comparation of dexmedetomidine and midazolam for sedation in patients with mechanical ventilation in ICU: A systematic review and meta-analysis. PloS One. 2023;18(11):e0294292.
Gupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol. 2017;33(2):236-40.
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LHY. A Double-Blind, Crossover Assessment of the Sedative and Analgesic Effects of Intranasal Dexmedetomidine. Anesth Analg. 2007;105(2):374-80.
Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015;115(2):171-82.
Liu Y, Liang F, Liu X, Shao X, Jiang N, Gan X. Dexmedetomidine Reduces Perioperative Opioid Consumption and Postoperative Pain Intensity in Neurosurgery: A Meta-analysis. J Neurosurg Anesthesiol. 2018;30(2):146-55.
Tsaousi GG, Pourzitaki C, Aloisio S, Bilotta F. Dexmedetomidine as a sedative and analgesic adjuvant in spine surgery: a systematic review and meta-analysis of randomized controlled trials. Eur J Clin Pharmacol. 2018;74(11):1377-89.
Zhang X, Bai Y, Shi M, Ming S, Jin X, Xie Y. Effect of different administration and dosage of dexmedetomidine in the reduction of emergence agitation in children: a meta-analysis of randomized controlled trials with sequential trial analysis. Transl Pediatr. 2021;10(4):929-57.
Xiong J, Gao J, Pang Y, Zhou Y, Sun Y, Sun Y. Dexmedetomidine premedication increases preoperative sedation and inhibits stress induced by tracheal intubation in adult: a prospective randomized double-blind clinical study. BMC Anesthesiol. 2022;22(1):398.
Na HS, Kim SY, In Park J, Lee S, Hwang JW, Shin HJ. The effect of intranasal dexmedetomidine administration on emergence agitation or delirium in pediatric patients after general anesthesia: A meta‐analysis of randomized controlled trials. Pediatr Anesth. 2023;33(8):636-46.
Hebbar KC, Reddy A, Luthra A, Chauhan R, Meena SC, Tripathi M. Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in children undergoing spinal dysraphism surgery: A randomized controlled trial. Eur J Anaesthesiol. 2024;41(4):288-95.
Keles S, Kocaturk O. Comparison of oral dexmedetomidine and midazolam for premedication and emergence delirium in children after dental procedures under general anesthesia: a retrospective study. Drug Des Devel Ther. 2018;12:647-53.
Cho EA, Cha YB, Shim JG, Ahn JH, Lee SH, Ryu KH. Comparison of single minimum dose administration of dexmedetomidine and midazolam for prevention of emergence delirium in children: a randomized controlled trial. J Anesth. 2020;34(1):59-65.
Tharu V, Paliwal N, Bihani P, Janweja S, Jaju R, Kothari S. Comparison of bolus dose administration of propofol and dexmedetomidine for incidence of emergence delirium in pediatric patients undergoing surgery with general anesthesia: A randomized, double-blind trial. J Anaesthesiol Clin Pharmacol. 9900;40(4):693-8.
- 摘要 ##plugins.themes.ojsPlusA.frontend.article.viewed##: 357 ##plugins.themes.ojsPlusA.frontend.article.times##
- pdf (English) ##plugins.themes.ojsPlusA.frontend.article.downloaded##: 687 ##plugins.themes.ojsPlusA.frontend.article.times##
##plugins.themes.ojsPlusA.frontend.article.downloadstatastics##
##plugins.block.makeSubmission.linkLabel##
SJR
COPE
