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

NCT07268924 | Not Yet Recruiting Phase 4

• 1 other identifier: EA-CHT-PvL-2025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Delirium, Anesthesia

Keywords

Emergence agitation in anesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

  Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).

  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

  Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).

  Within 30 minutes after extubation.

Secondary Outcomes (6)

• emergence time from anesthesia

  Within 30 minutes after extubation.

• peaked PAED scores

  Within 30 minutes after extubation.

• extubation time

  Within 30 minutes after extubation.

• post-operative pain using FLACC score

  Within 30 minutes after extubation.

• Hemodynamic effects as hypotention and bradycardia

  Within 30 minutes after extubation.

Study Arms (2)

Group ( p ) recieve 1mg /kg of propofol

ACTIVE COMPARATOR

Drug: Propofol

Group ( L ) recieve 1.5 mg/kg of lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine %2 ampoule

Interventions

Propofol DRUG

In pediatric tonsillectomy after the end of surgery, patient will recieve 1 mg/kg of propofol iv bolus

Group ( p ) recieve 1mg /kg of propofol

Lidocaine %2 ampoule DRUG

In pediatric tonsillectomy after the end of the surgery , patient will recieve 1.5 mg/kg of lidocaine iv bolus

Group ( L ) recieve 1.5 mg/kg of lidocaine

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• emergency cases as bleeding tonsills
• ASA III OR IV

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (14)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Na HS, Song IA, Hwang JW, Do SH, Oh AY. Emergence agitation in children undergoing adenotonsillectomy: a comparison of sevoflurane vs. sevoflurane-remifentanil administration. Acta Anaesthesiol Scand. 2013 Jan;57(1):100-5. doi: 10.1111/aas.12006. Epub 2012 Oct 30.

  PMID: 23110746 RESULT

• Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.

  PMID: 26601849 RESULT

• Acar HV, Yilmaz A, Demir G, Eruyar SG, Dikmen B. Capsicum plasters on acupoints decrease the incidence of emergence agitation in pediatric patients. Paediatr Anaesth. 2012 Nov;22(11):1105-9. doi: 10.1111/j.1460-9592.2012.03876.x.

  PMID: 22553919 RESULT

• Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.

  PMID: 40090678 RESULT

• Xie M, Li XK, Peng Y. Magnesium sulfate for postoperative complications in children undergoing tonsillectomies: a systematic review and meta-analysis. J Evid Based Med. 2017 Feb;10(1):16-25. doi: 10.1111/jebm.12230.

  PMID: 27787936 RESULT

• Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Mansson I, Roos K, Hessen Soderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. doi: 10.3109/00016489.2011.644252. Epub 2012 Jan 11.

  PMID: 22235871 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Hesham Bahaaeldin Mohamed, Resident doctor

CONTACT

+201069896083; heshambahaa51@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at anesthesia & ICU depatrtment

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)