The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.

Overview

This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.

Detailed description

Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation .

Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery.

Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA .

Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA.

So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?

Interventions

• Drug Propofol
  In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus
• Drug Lidocaine %2 ampoule
  In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Primary outcome measures

• To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale. [Time frame: Within 30 minutes after extubation]
• To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale [Time frame: Within 30 minutes after extubation.]

Secondary outcome measures (6)

• emergence time from anesthesia [Time frame: Within 30 minutes after extubation.]
• peaked PAED scores [Time frame: Within 30 minutes after extubation.]
• extubation time [Time frame: Within 30 minutes after extubation.]
• post-operative pain using FLACC score [Time frame: Within 30 minutes after extubation.]
• Hemodynamic effects as hypotention and bradycardia [Time frame: Within 30 minutes after extubation.]
• Post operative nausea and vomitting [Time frame: Within 30 minutes after extubation.]

Eligibility criteria

Inclusion criteria

• Elective tonsillectomy operation
• pediaterics between ( 4 : 7 ) years old
• ASA I OR II

Exclusion criteria

• emergency cases as bleeding tonsills
• ASA III OR IV

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Egypt · 1 center

• Assiut university hospitals — Asyut

Publications

• Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr. PMID 31341828
• Ji JY, Park JS, Kim JE, Kim DH, Chung JH, Chun HR, Jung HS, Yoo SH. Effect of esmolol and lidocaine on agitation in awake phase of anesthesia among children: a double-blind, randomized clinical study. Chin Med J (Engl). 2019 Apr 5;132(7):757-764. doi: 10.1097/CM9.0000000000000141. PMID 30741832
• Manouchehrian N, Jiryaee N, Moheb FA. Propofol versus lidocaine on prevention of laryngospasm in tonsillectomy: A randomized clinical trial. Eur J Transl Myol. 2022 Jun 29;32(3):10581. doi: 10.4081/ejtm.2022.10581. PMID 35766592
• Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. doi: 10.1007/BF03008224. PMID 1394752
• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. PMID 15114210
• Clivio S, Putzu A, Tramer MR. Intravenous Lidocaine for the Prevention of Cough: Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Nov;129(5):1249-1255. doi: 10.1213/ANE.0000000000003699. PMID 30169416
• Mokhtar AM, Badawy AA. [Low dose propofol vs. lidocaine for relief of resistant post-extubation laryngospasm in the obstetric patient]. Braz J Anesthesiol. 2018 Jan-Feb;68(1):57-61. doi: 10.1016/j.bjan.2017.03.009. Epub 2017 Jul 25. PMID 28754225
• Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x. PMID 16677266

Identifiers

NCT: NCT07268924 · EA-CHT-PvL-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗