Effect of Different Drugs on Emergency Delirium in Preschool Age Patient
NCT ID: NCT07057193
Last Updated: 2025-07-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
92 participants
INTERVENTIONAL
2025-07-15
2026-01-30
Brief Summary
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The risk factors to postoperative ED are patients' characters (preschool age and preexisting behavior), the surrounding environment as parental anxiety, type of anesthesia (volatile anesthetics) as sevoflurane or halothane and the type of surgery as tonsillectomy, adenoidectomy, and strabismus surgery which is one of the most commonly undertaken surgeries in pediatric patients. It may cause visual disturbance in the recovery phase, which can result. In order to diagnose ED, the presence of pain during recovery from general anesthesia must be ruled out because it leads to a change in behavior that resembles delirium. Fortunately, one of the advantages of using the Pediatric Anesthesia Emergence Delirium (PAED) scale is its ability to distinguish between the ED and the change in behavior resulting from pain, because it focuses on changes in awareness and knowledge that are not changed by pain. Prophylactic drugs against the occurrence of postoperative ED include the adjuvant use of α2 adrenoreceptor agonists such as dexmedetomidine, ketamine, midazolam, propofol, and fentanyl. The use of these drugs with them adverse effects should be weighed against the fact that postoperative ED is a self-limited disorder. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that is associated with sedative and analgesic sparing effects. It is commonly used for prevention of emergence delirium and agitation, perioperative sympatholysis, cardiovascular stabilization, and preservation of respiratory function. Ketamine is a dissociative anesthetic. Its mechanism of action is mainly via a noncompetitive antagonism of the N - methyl - D - aspartic acid (NMDA) receptor. It also targets other receptors, such as a - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazolepropionic acid (AMPA) receptors, and has additional acts as an agonist of the sigma 1 receptor. It is commonly used for acute pain management, chronic pain management, prevention of ED, and postoperative nausea and vomiting. Midazolam is short acting benzodiazepine which is central nervous system depressant. It is commonly used for premedication during pediatric anesthesia, for prevention of emotional distress and ED due to its sedative and anxiolytic properties, additionally it used for reduction of the analgesic requirement and to prevent postoperative nausea and vomiting
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group (C group)
patients will receive 5ml of normal saline intravenous10 min before the end of the surgical procedure as placebo.
5ml of normal saline
patients will receive 5ml of normal saline intravenous10 min before the end of the surgical procedure as placebo.
Dexmedetomidine group (D group)
patients will receive intravenous dexmedetomidine (0.25 μg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Dexmedetomidine group (D group)
patients will receive intravenous dexmedetomidine (0.25 μg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Ketamine group (K group)
patients will receive intravenous ketamine (0.25mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Ketamine group (K group)
patients will receive intravenous ketamine (0.25mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Midazolam group (M group)
patients will receive intravenous midazolam (0.05 mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Midazolam group (M group)
patients will receive intravenous midazolam (0.05 mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Interventions
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Dexmedetomidine group (D group)
patients will receive intravenous dexmedetomidine (0.25 μg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Ketamine group (K group)
patients will receive intravenous ketamine (0.25mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Midazolam group (M group)
patients will receive intravenous midazolam (0.05 mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
5ml of normal saline
patients will receive 5ml of normal saline intravenous10 min before the end of the surgical procedure as placebo.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
5 Years
ALL
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Asmaa Mohammed Galal El-Deen
lecturer of anesthesia and surgical intensive care
Central Contacts
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References
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Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.
Wang HY, Chen TY, Li DJ, Lin PY, Su KP, Chiang MH, Carvalho AF, Stubbs B, Tu YK, Wu YC, Roerecke M, Smith L, Tseng PT, Hung KC. Association of pharmacological prophylaxis with the risk of pediatric emergence delirium after sevoflurane anesthesia: An updated network meta-analysis. J Clin Anesth. 2021 Dec;75:110488. doi: 10.1016/j.jclinane.2021.110488. Epub 2021 Sep 1.
Uakritdathikarn T, Chongsuvivatwong V, Geater AF, Vasinanukorn M, Thinchana S, Klayna S. Perioperative desaturation and risk factors in general anesthesia. J Med Assoc Thai. 2008 Jul;91(7):1020-9.
Templeton TW, Goenaga-Diaz EJ, Downard MG, McLouth CJ, Smith TE, Templeton LB, Pecorella SH, Hammon DE, O'Brien JJ, McLaughlin DH, Lawrence AE, Tennant PR, Ririe DG. Assessment of Common Criteria for Awake Extubation in Infants and Young Children. Anesthesiology. 2019 Oct;131(4):801-808. doi: 10.1097/ALN.0000000000002870.
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Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
Kim YH, Yoon SZ, Lim HJ, Yoon SM. Prophylactic use of midazolam or propofol at the end of surgery may reduce the incidence of emergence agitation after sevoflurane anaesthesia. Anaesth Intensive Care. 2011 Sep;39(5):904-8. doi: 10.1177/0310057X1103900516.
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Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
Fang XZ, Gao J, Ge YL, Zhou LJ, Zhang Y. Network Meta-Analysis on the Efficacy of Dexmedetomidine, Midazolam, Ketamine, Propofol, and Fentanyl for the Prevention of Sevoflurane-Related Emergence Agitation in Children. Am J Ther. 2016 Jul-Aug;23(4):e1032-42. doi: 10.1097/MJT.0000000000000321.
ECKENHOFF JE, KNEALE DH, DRIPPS RD. The incidence and etiology of postanesthetic excitment. A clinical survey. Anesthesiology. 1961 Sep-Oct;22:667-73. doi: 10.1097/00000542-196109000-00002. No abstract available.
Doerrfuss JI, Kramer S, Tafelski S, Spies CD, Wernecke KD, 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 Jun;85(6):617-624. doi: 10.23736/S0375-9393.19.13038-6. Epub 2019 Jan 18.
Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
Bong CL, Lim E, Allen JC, Choo WL, Siow YN, Teo PB, Tan JS. A comparison of single-dose dexmedetomidine or propofol on the incidence of emergence delirium in children undergoing general anaesthesia for magnetic resonance imaging. Anaesthesia. 2015 Apr;70(4):393-9. doi: 10.1111/anae.12867. Epub 2014 Oct 14.
Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
Related Links
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Other Identifiers
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Zagazig S
Identifier Type: -
Identifier Source: org_study_id
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