Emergence AgitationNCT07435675
Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.
A study testing ultrasound-guided greater auricular nerve block (GANB) in people with Emergence Agitation and Emergence Delirium, Anesthesia, run by Fayoum University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation, Emergence Delirium, Anesthesia, Emergence From Anesthesia
- What is being tested?
- ultrasound-guided greater auricular nerve block (GANB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Informed consent obtained from a parent or legal guardian.
Who cannot join
- 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.
- Inability to assess pain or agitation due to hearing loss, or communication impairment.
- Parental or legal guardian refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum University Hospital
Al Fayyum, Faiyum Governorate, 63511
abdalla moustafa abdelhamid, MBCCH, 00201066743988, am3486@fayoum.edu.eg
About this study
Official title: Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery: A PROSPECTIVE RANDOMIZED DOUBLE- BLINDED CLINICAL 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.
Read the detailed description
Emergence agitation (EA) is one of the Perioperative Neurocognitive Disorders (PND). It's defined as psychomotor agitation and delirium, that typically occurs within the first 45 minutes postoperative. It may present as non-purposeful movements such as kicking and pulling or lack of eye contact or awareness to the surroundings.
EA has been linked to several risk factors, including type of surgery (ENT, ophthalmic), the use of volatile anesthetics (especially sevoflurane) . Middle earsurgeries are especially noteworthy because of their high EA risk owing to significant nociceptive stimulation of the external ear and its surrounding tissues as well. Pain is one of the modifiable risk factors, and studies have demonstrated a strong association between postoperative pain scores and incidence of EA The greater auricular nerve (GAN), originating from the cervical plexus (C2-C3), provides sensory innervation to the inferior two-thirds of the auricle, skin over the mastoid process, angle of the mandible and parotid region (5). All these areas are typically involved in or manipulated for middle ear surgery, and therefore the GAN is an easily identifiable nerve for perioperative analgesia treatment. An ultrasound-guided GAN block has been performed in both adults and pediatric populations to provide analgesia for postoperative pain after parotidectomy, auriculotemporal procedures, and mastoid surgery (6,7).
The strong association between moderate to severe postoperative pain and EA, coupled with the high rate of EA in middle ear procedures, suggest that a safe, focused regional technique could address these issues in this population (8). That in mind, we hypothesize that using an ultrasound-guided technique giving 100% accuracy blocking GAN, will reduce the pain and hence the incidence of EA postoperative.
- Conditions
- Emergence Agitation, Emergence Delirium, Anesthesia, Emergence From Anesthesia, Emergence Delirium, Emergence Delirium in Pediatric Anesthesia, Emergence Agitation, Post Operative Behavioral Changes
- Being tested
- ultrasound-guided greater auricular nerve block (GANB)
- Keywords
- emergence agitation, emergence delirium, EA
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided greater auricular nerve block (GANB)Procedure or surgery
ultrasound-guided greater auricular nerve block (GANB)
| Study group | Role | What they receive |
|---|---|---|
| group G (GANB group) | Experimental | Patients in this group will receive a unilateral ultrasound-guided greater auricular nerve block (GANB) on the operative side, with a 0.5-1.5 mg/kg 0.25% Bupivacaine, immediately after induction of general anesthesia and prior to surgical incision Receives: Procedure: ultrasound-guided greater auricular nerve block (GANB) |
| group C (control group) | No intervention | Patients in this group will receive no nerve block, to maintain blinding, the ultrasound probe will be applied to the same anatomical region with no needle insertion or injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.
Secondary outcomes (6)
Time to emergence
It's the time between cessation of any anesthetic agent and emergence, as it contributes to agitation.
Measured: From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.
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)
Measured: Post-extubation up to 2 hours.
Requirement for rescue analgesia or rescue sedation
If the incidence of EA or pain occurs, medical intervention will be commenced.
Measured: Postoperative from emergence up to 2 hours.
Total PACU stay duration
this will record time to discharge from PACU. The shorter the time the more favorable the intervention is.
Measured: from emergence up to 3 hours.
Incidence of postoperative nausea and vomiting (PONV)
PONV is considered an adverse outcome of many factors in perioperative period, including opioid use, pain, preoperative GERD or incomplete hours of fasting.
Measured: From emergence up to 2 hours.
Incidence of oxygen desaturation (SpO₂ <94%)
Hypoxia may result from aspiration, incomplete recovery from muscle relaxants, oversedation, or preexisting respiratory problems.
Measured: from emergence up to 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Moustafa Hassan Abdelhamid, Fayoum University
- Investigators
- mohamed ahmed Ismail, professor, Study chair, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435675
- Sponsor's protocol ID
- M824
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei B, Feng Y, Chen W, Ren D, Xiao D, Chen B. Risk factors for emergence agitation in adults after general anesthesia: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2021 Jul;65(6):719-729. doi: 10.1111/aas.13774. Epub 2021 Jan 7.
PubMed 33370461Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
PubMed 29319604Flores S, Herring AA. Ultrasound-guided Greater Auricular Nerve Block for Emergency Department Ear Laceration and Ear Abscess Drainage. J Emerg Med. 2016 Apr;50(4):651-5. doi: 10.1016/j.jemermed.2015.10.003. Epub 2015 Nov 14.
PubMed 26589558Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
PubMed 12760985Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.
PubMed 24784918Urits I, Peck J, Giacomazzi S, Patel R, Wolf J, Mathew D, Schwartz R, Kassem H, Urman RD, Kaye AD, Viswanath O. Emergence Delirium in Perioperative Pediatric Care: A Review of Current Evidence and New Directions. Adv Ther. 2020 May;37(5):1897-1909. doi: 10.1007/s12325-020-01317-x. Epub 2020 Apr 9.
PubMed 32274749
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery: A PROSPECTIVE RANDOMIZED DOUBLE- BLINDED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07435675
- Acronym / sponsor ID
- M824
- Conditions
- Emergence Agitation, Emergence Delirium, Anesthesia, Emergence From Anesthesia, Emergence Delirium, Emergence Delirium in Pediatric Anesthesia, Emergence Agitation, Post Operative Behavioral Changes
- Keywords
- emergence agitation, emergence delirium, EA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Emergence agitation (EA) is one of the Perioperative Neurocognitive Disorders (PND). It's defined as psychomotor agitation and delirium, that typically occurs within the first 45 minutes postoperative. It may present as non-purposeful movements such as kicking and pulling or lack of eye contact or awareness to the surroundings.
EA has been linked to several risk factors, including type of surgery (ENT, ophthalmic), the use of volatile anesthetics (especially sevoflurane) . Middle earsurgeries are especially noteworthy because of their high EA risk owing to significant nociceptive stimulation of the external ear and its surrounding tissues as well. Pain is one of the modifiable risk factors, and studies have demonstrated a strong association between postoperative pain scores and incidence of EA The greater auricular nerve (GAN), originating from the cervical plexus (C2-C3), provides sensory innervation to the inferior two-thirds of the auricle, skin over the mastoid process, angle of the mandible and parotid region (5). All these areas are typically involved in or manipulated for middle ear surgery, and therefore the GAN is an easily identifiable nerve for perioperative analgesia treatment. An ultrasound-guided GAN block has been performed in both adults and pediatric populations to provide analgesia for postoperative pain after parotidectomy, auriculotemporal procedures, and mastoid surgery (6,7).
The strong association between moderate to severe postoperative pain and EA, coupled with the high rate of EA in middle ear procedures, suggest that a safe, focused regional technique could address these issues in this population (8). That in mind, we hypothesize that using an ultrasound-guided technique giving 100% accuracy blocking GAN, will reduce the pain and hence the incidence of EA postoperative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group G (GANB group) | Experimental | Procedure: ultrasound-guided greater auricular nerve block (GANB)Patients in this group will receive a unilateral ultrasound-guided greater auricular nerve block (GANB) on the operative side, with a 0.5-1.5 mg/kg 0.25% Bupivacaine, immediately after induction of general anesthesia and prior to surgical incision |
| group C (control group) | No intervention | –Patients in this group will receive no nerve block, to maintain blinding, the ultrasound probe will be applied to the same anatomical region with no needle insertion or injection |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Informed consent obtained from a parent or legal guardian.
Key exclusion criteria (6 listed)
- 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.
- Inability to assess pain or agitation due to hearing loss, or communication impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided greater auricular nerve block (GANB)ultrasound-guided greater auricular nerve block (GANB) | Procedure or surgery | group G (GANB group) |
Primary outcome
score on Pediatric Anesthesia Emergence Delirium (PAED) scale.
Time frame: Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.
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.
6 secondary outcomes
Time to emergence
Time frame: From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.
Postoperative pain intensity
Time frame: Post-extubation up to 2 hours.
Requirement for rescue analgesia or rescue sedation
Time frame: Postoperative from emergence up to 2 hours.
Total PACU stay duration
Time frame: from emergence up to 3 hours.
Incidence of postoperative nausea and vomiting (PONV)
Time frame: From emergence up to 2 hours.
Incidence of oxygen desaturation (SpO₂ <94%)
Time frame: from emergence up to 2 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 33370461Wei B, Feng Y, Chen W, Ren D, Xiao D, Chen B. Risk factors for emergence agitation in adults after general anesthesia: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2021 Jul;65(6):719-729. doi: 10.1111/aas.13774. Epub 2021 Jan 7.
- Background: PubMed 29319604Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
- Background: PubMed 26589558Flores S, Herring AA. Ultrasound-guided Greater Auricular Nerve Block for Emergency Department Ear Laceration and Ear Abscess Drainage. J Emerg Med. 2016 Apr;50(4):651-5. doi: 10.1016/j.jemermed.2015.10.003. Epub 2015 Nov 14.
- Background: PubMed 12760985Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
- Background: PubMed 24784918Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.
- Background: PubMed 32274749Urits I, Peck J, Giacomazzi S, Patel R, Wolf J, Mathew D, Schwartz R, Kassem H, Urman RD, Kaye AD, Viswanath O. Emergence Delirium in Perioperative Pediatric Care: A Review of Current Evidence and New Directions. Adv Ther. 2020 May;37(5):1897-1909. doi: 10.1007/s12325-020-01317-x. Epub 2020 Apr 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohamed ahmed Ismail, professor study chair
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided greater auricular nerve block (GANB) in people with Emergence Agitation and Emergence Delirium, Anesthesia, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact abdalla moustafa abdelhamid, MBBCH (00201066743988, am3486@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score on Pediatric Anesthesia Emergence Delirium (PAED) scale. (time frame: Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435675, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.