Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy

Part of paid clinical trials in Mobile, Alabama.

Sponsor
University of South Alabama
Study ID
NCT07276906
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
6 Months - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Fentanyl — DRUG
    Intramuscular fentanyl 2 mcg/kg (maximum 100 mcg) administered after induction of anesthesia
  • Ketorolac — DRUG
    Intramuscular ketorolac 0.5 mg/kg (maximum 30 mg) administered after induction of anesthesia
  • Nerve of Arnold Block — PROCEDURE
    Bilateral Nerve of Arnold block with bupivacaine 0.25%, 0.2 mL per side (total 0.4 mL), administered after induction of anesthesia
  • Sham Intramuscular Injection — PROCEDURE
    sham intramuscular injections with normal saline to maintain blinding
  • Sham Nerve of Arnold Block — PROCEDURE
    Bilateral sham Nerve of Arnold block with normal saline 0.2 mL per side to maintain blinding
  • Dexmedetomidine — DRUG
    Dexmedetomidine 5 mcg per side (10 mcg total) added to bupivacaine solution for Nerve of Arnold block as adjuvant to prolong block duration
  • Bupivacaine — DRUG
    Bupivacaine 0.25% with epinephrine 1:200,000, 0.2 mL per side (total 0.4 mL, maximum 2.5 mg/kg) for bilateral Nerve of Arnold block

Study Details

Background: Bilateral myringotomy with tympanostomy tube (BMT) placement is one of the most common pediatric surgical procedures. Despite its brief duration, many children experience significant postoperative pain. Current standard care typically involves intramuscular (IM) administration of an opioid (fentanyl) combined with a non-steroidal anti-inflammatory drug (ketorolac). While this multimodal approach provides adequate pain control for approximately 75% of children, it is associated with opioid-related side effects including respiratory depression, nausea, vomiting, and sedation. Additionally, nearly one-quarter of children still experience moderate-to-severe pain despite this regimen. The Nerve of Arnold block is a regional anesthesia technique that involves injection of local anesthetic near the auricular branch of the vagus nerve, which provides sensory innervation to the external auditory canal and tympanic membrane. This technique offers the potential for targeted, opioid-sparing analgesia with extended duration and minimal systemic side effects. However, high-quality evidence comparing this regional technique to standard systemic analgesia in pediatric patients is lacking. Study Objective: This study aims to determine whether the Nerve of Arnold block is non-inferior to the standard combination of IM fentanyl and IM ketorolac in controlling postoperative pain in children undergoing BMT placement. Study Design: This is a prospective, randomized, double-blind, non-inferiority trial. Three hundred children aged 6 months to 6 years scheduled for bilateral myringotomy with tympanostomy tube placement will be randomized 1:1 to receive either: (1) Standard care: IM fentanyl (1-2 mcg/kg) plus IM ketorolac (0.5 mg/kg) with sham Nerve of Arnold block, or (2) Intervention: Bilateral Nerve of Arnold block with bupivacaine 0.25% plus sham IM injections. Both patients and outcome assessors will be blinded to treatment assignments. Primary Outcome: The proportion of patients experiencing moderate-to-severe pain (Face, Legs, Activity, Cry, Consolability \[FLACC\] scale score ≥4) in the Post-Anesthesia Care Unit (PACU). Non-inferiority will be declared if the upper bound of the 95% confidence interval for the difference in proportions is less than 10 percentage points. Secondary Outcomes: Secondary outcomes include mean and maximum FLACC scores, rescue analgesic requirements, respiratory depression, postoperative nausea and vomiting, PACU length of stay, parent satisfaction, and pain at 24 hours postoperatively. Clinical Significance: If the Nerve of Arnold block is shown to be non-inferior to standard care, it could provide a valuable opioid-sparing alternative for postoperative pain management in pediatric ear surgery, potentially reducing opioid-related adverse events while maintaining effective analgesia. This would be particularly beneficial for patients with contraindications to opioids or NSAIDs and aligns with national efforts to reduce opioid exposure in pediatric populations.

Key Dates

Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: IM Arm standard Care
    Patients receive intramuscular fentanyl 2 mcg/kg (maximum 100 mcg) plus intramuscular ketorolac 0.5 mg/kg (maximum 30 mg) after induction of anesthesia. Sham bilateral Nerve of Arnold block with normal saline 0.2 mL per side is performed to maintain blinding.
  • Experimental: Nerve block arm
    Patients receive bilateral Nerve of Arnold block with bupivacaine 0.25% with epinephrine 1:200,000 (0.2 mL per side) plus dexmedetomidine 5 mcg per side (maximum total bupivacaine dose 2.5 mg/kg) after induction of anesthesia. sham intramuscular injection with normal saline is performed to maintain blinding.

Primary Outcome Measure

Number of Participants with Moderate-to-Severe Pain (FLACC Score ≥4) During PACU Stay [ Time Frame: From PACU admission to PACU discharge, up to 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children and Woman's HospitalMobileAlabama36604
Karthik Swamy, MD
[email protected]
251-471-7045
Karthik Swamy, M.D
[email protected]
251-471-7045

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By research site
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