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Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.

ConditionsEmergence AgitationEmergence Delirium, AnesthesiaEmergence From AnesthesiaEmergence DeliriumEmergence Delirium in Pediatric AnesthesiaEmergence Agitation, Post Operative Behavioral Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorFayoum University

About this trial

This study is designed to evaluate the effectiveness of ultrasound-guided greater auricular nerve block (GAN) on the reduction of emergence agitation (EA) occurrence and EA severity in children who are receiving general anesthesia for a microscopic middle ear operation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 5 and 14 years (preschool to early school age group at highest risk for EA).

ASA physical status I or II.

Scheduled for elective microscopic middle ear surgery under general anesthesia (e.g., tympanoplasty, myringoplasty).

Ability to comply with FLACC and PAED scoring during postoperative period.

Disqualifiers

Known neurological, developmental, or psychiatric disorders (e.g., autism, ADHD, seizure disorder).

Known hypersensitivity to amide local anesthetics (e.g., lidocaine, bupivacaine).

Skin infection, hematoma, or trauma at or near the proposed block site.

Non-elective (emergency) or combined surgeries.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided greater auricular nerve block (GANB)

    Procedure/Surgery

    ultrasound-guided greater auricular nerve block (GANB)

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: group G (GANB group)Experimental treatment 1 intervention
Group B: group C (control group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

score on Pediatric Anesthesia Emergence Delirium (PAED) scale.

The Pediatric Anesthesia Emergence Delirium (PAED) scale has 64% sensitivity and 86% specificity. This validated tool includes five items scored on a 5-point Likert scale (eye contact with caregiver, purposeful actions, awareness of surroundings, restlessness, and consolability). Score of ≥10 at any point during the postoperative observation period in the PACU will be considered as an episode of EA.

Time frame
Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.

Secondary outcomes

1

Time to emergence

It's the time between cessation of any anesthetic agent and emergence, as it contributes to agitation.

Time frame
From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.
2

Postoperative pain intensity

Pain will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, scored from 0 to 10. Pain scores will be assessed: * At 5-minute intervals during the first 30 minutes post-extubation * Then every 15 minutes until PACU discharge * FLACC ≥4 will trigger rescue analgesia with IV nalbuphine (0.1 mg/kg)

Time frame
Post-extubation up to 2 hours.
3

Requirement for rescue analgesia or rescue sedation

If the incidence of EA or pain occurs, medical intervention will be commenced.

Time frame
Postoperative from emergence up to 2 hours.
4

Total PACU stay duration

this will record time to discharge from PACU. The shorter the time the more favorable the intervention is.

Time frame
from emergence up to 3 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fayoum University

Lead sponsor

Source ClinicalTrials.gov
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