Magnesium Sulfate Versus Other Anesthesia Drugs to Reduce Agitation After Adenotonsillectomy in Pediatric Patients (POEA)

Different Anesthetic Approaches on Postoperative Emergence Agitation in Pediatric Patients Undergoing Adenotonsillectomy: a Prospective Randomized Study

Background: Adenotonsillectomy is one of the most common pediatric surgeries and is often complicated by postoperative emergence agitation (POEA), a short-lived but distressing state of confusion and restlessness after anesthesia. POEA may decrease comfort and increase the risk of perioperative complications.

Objective: To compare four commonly used anesthetic strategies-propofol bolus, ketamine bolus, lidocaine infusion, and magnesium sulfate infusion-with respect to POEA and early recovery quality in children undergoing adenotonsillectomy.

Methods: In this single-center, prospective randomized trial, 100 children aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy were assigned to one of four anesthetic groups. All patients received standardized premedication, intraoperative management, and multimodal analgesia. Postoperative complications, analgesic requirements, postoperative nausea and vomiting (PONV), time to eye opening, duration of stay in the post-anesthesia care unit (PACU), vital signs, Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS) were recorded and compared.

Study Overview

• Status: Completed
• Conditions: Adenotonsillar Hypertrophy; Anesthesia Emergence Delirium
• Intervention / Treatment: Drug: Magnesium sulfate (MgSO4) infusion; Drug: Propofol bolus; Drug: Ketamine bolus; Drug: Lidocaine Infusion

Detailed Description

Adenotonsillectomy operations are the most common childhood surgeries. Although they are so common, still adenotonsillectomy procedures remain challenging with increased risks of morbidity and mortality for both the surgeon and the anesthesiologist .

Postanesthetic emergence agitation (POEA) is a temporary state of dissociated consciousness during recovery from general anesthesia, in which the child is irritable, uncooperative, restless, and often crying. Reported incidence ranges from 10% to 80%, and POEA is particularly common after ear, nose, and throat (ENT) procedures, including adenotonsillectomy. POEA is usually self-limited, children suffer anxiety, fasting , they are afraid of uncertainty, pain and seperation from parents .POEA needs special consideration because it may lead to self-injury, disruption of surgical sites, removal of catheters or tubes, and delayed discharge from the post-anesthesia care unit (PACU).

Various pharmacological strategies have been investigated to reduce POEA, including propofol, ketamine, magnesium sulfate, lidocaine, opioids, benzodiazepines, clonidine, and α2-agonists, with conflicting results . However, the optimal anesthetic strategy to minimize POEA while preserving efficient recovery remains unclear. The investigators therefore designed a prospective randomized study to compare four anesthetic approaches-propofol, ketamine, lidocaine, and magnesium sulfate-on POEA incidence, recovery characteristics, and perioperative complications in children undergoing adenotonsillectomy.

Methods This prospective randomized study was conducted at Gaziosmanpaşa Research and Training Hospital. The study protocol was approved by the institutional Ethics Committee, and written informed consent was obtained from the parents or legal guardians of all participants. The investigators enrolled 100 pediatric patients aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective adenotonsillectomy. Exclusion criteria included ASA III or higher, emergency surgery, communication barriers, history of allergy to any study medication, and known cognitive or developmental delay. All children were fasted according to standard guidelines.

Patients were randomized into four groups using a computer-generated sequence:

• Magnesium sulfate (MgSO4) group: MgSO4 infusion (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).
• Propofol group: propofol 1 mg/kg bolus administered before the end of surgery.
• Ketamine group: ketamine 2 mg/kg bolus administered after induction.
• Lidocaine group: lidocaine 1.5 mg/kg infusion over 15 minutes after induction. All patients received the same premedication (intravenous midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg intravenously as part of a multimodal analgesic regimen.

Hemodynamic variables were recorded intraoperatively. After emergence, the investigators documented time to eye opening, surgery duration, postoperative complications, need for rescue analgesia, and nausea and vomiting (PONV). Duration of stay in the post-anesthesia care unit ( PACU) was recorded from arrival until the discharge. Vital signs and pain-delirium scales were assessed at 5 and 15 minutes in the PACU and at 2 hours postoperatively in the ward . The following scales were used: Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS). Anesthesiologists responsible for intraoperative management did not participate in postoperative assessments.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34075
    • Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• pediatric patients aged 3-10 years
• American Society of Anesthesiologists (ASA) physical status I-II
• scheduled for elective adenotonsillectomy

Exclusion Criteria:

• ASA III or higher
• emergency surgery
• communication barriers
• history of allergy to any study medication
• known cognitive or developmental delay.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium sulfate (MgSO4) group; All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received MgSO4 infusion per protocol (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).	Drug: Magnesium sulfate (MgSO4) infusion; IV MgSO4 infusion: Loading dose 30 mg/kg over 10 minutes after tracheal intubation, followed by 10 mg/kg/h continuous infusion (duration per protocol / until end of surgery)."
Active Comparator: Propofol group; All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received propofol 1 mg/kg bolus before the end of surgery.	Drug: Propofol bolus; IV propofol 1 mg/kg bolus administered before the end of surgery (timing per protocol).
Active Comparator: Ketamine group; All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received ketamine 2 mg/kg bolus administered after induction.	Drug: Ketamine bolus; IV ketamine 2 mg/kg bolus administered after induction.
Active Comparator: Lidocaine group; All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen. Participants additionally received lidocaine 1.5 mg/kg infusion over 15 minutes after induction.	Drug: Lidocaine Infusion; IV lidocaine 1.5 mg/kg administered as an infusion over 15 minutes after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain in PACU (FLACC score)	Postoperative pain will be assessed in the post-anesthesia care unit (PACU) using the Face, Legs, Activity, Cry, Consolability (FLACC) pain score (range 0-10; higher scores indicate more severe pain). FLACC will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. Primary metric will be the maximum FLACC recorded within 120 minutes after PACU arrival.	From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
Emergence agitation/delirium in PACU (PAED score)	Emergence agitation/delirium will be assessed in the PACU using the Pediatric Anesthesia Emergence Delirium (PAED) score (range 0-20; higher scores indicate more severe agitation/delirium). PAED will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the maximum PAED score observed within the first 2 hours in the PACU. Primary metric will be the maximum PAED recorded within 120 minutes after PACU arrival.	From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
Early recovery status in PACU (Modified Aldrete Score, MAS)	Recovery status will be assessed in the PACU using the Modified Aldrete Score (MAS) (range 0-10; higher scores indicate better recovery). MAS will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the minimum MAS observed within the first 2 hours in the PACU.	From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea and vomiting (PONV)	Postoperative nausea and vomiting (PONV) will be assessed in the post-anesthesia care unit (PACU). PONV will be defined as any episode of nausea (patient report) and/or vomiting/retching (observed). The outcome will be recorded as the proportion of participants who experience PONV and the number of vomiting/retching episodes. Administration of rescue antiemetic medication during the assessment period will also be recorded.	From PACU arrival (0 minutes) up to 120 minutes postoperatively
Time to eye opening after discontinuation of anesthetic agents	Time to eye opening will be defined as the elapsed time from discontinuation of anesthetic agents at the end of surgery to the first observed spontaneous eye opening, assessed by a trained observer in the operating room and/or during transfer to the PACU. The outcome will be recorded in minutes for each participant.	From discontinuation of anesthetic agents at the end of surgery to the time of first spontaneous eye opening, assessed from end of surgery up to 2 hours postoperatively
Length of stay in the post-anesthesia care unit (PACU)	PACU length of stay will be defined as the elapsed time from PACU arrival to PACU discharge readiness and actual discharge per institutional criteria, documented in the medical record. The outcome will be recorded in minutes for each participant.	From PACU arrival until PACU discharge up to 120 minutes

Collaborators and Investigators

• Sponsor: Ayfer Kaya Gök
• Investigators: Principal Investigator: Ayfer Kaya Gök, gaziosmanpaşa training and research hospital md

Publications and helpful links

General Publications

• Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.
• Becke K. Anesthesia for ORL surgery in children. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2014 Dec 1;13:Doc04. doi: 10.3205/cto000107. eCollection 2014.
• Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.
• Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.
• Koo CH, Koo BW, Han J, Lee HT, Lim D, Shin HJ. The effects of intraoperative magnesium sulfate administration on emergence agitation and delirium in pediatric patients: A systematic review and meta-analysis of randomized controlled trials. Paediatr Anaesth. 2022 Apr;32(4):522-530. doi: 10.1111/pan.14352. Epub 2021 Dec 7.
• Haile S, Girma T, Akalu L. Effectiveness of propofol on incidence and severity of emergence agitation on pediatric patients undergo ENT and ophthalmic surgery: Prospective cohort study design. Ann Med Surg (Lond). 2021 Aug 24;69:102765. doi: 10.1016/j.amsu.2021.102765. eCollection 2021 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Adenotonsillectomy; Pediatric anesthesia; Postoperative emergence agitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate
• Other Study ID Numbers: 2023-65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No