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NCT07276906 · ClinicalTrials.gov registry record · Phase 4
Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy
A Phase 4 study, sponsored by University of South Alabama.
- Not yet
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT07276906: Clinical Trial Phase 4 study, sponsored by University of South Alabama.
NCT07276906 is a Phase 4 study that has not yet begun recruiting, run by University of South Alabama. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07276906, a Phase 4 study, has not yet begun recruiting, sponsored by University of South Alabama.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
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 o
Interventions
- DRUG Ketorolac
- DRUG Fentanyl
- PROCEDURE Nerve of Arnold Block
- PROCEDURE Sham Intramuscular Injection
- PROCEDURE Sham Nerve of Arnold Block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-01 |
| Est. Completion | 2026-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07276906
The ClinicalTrials.gov registry entry for NCT07276906 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Alabama, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ketorolac is the first listed.
NCT07276906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07276906 about?
NCT07276906 is a clinical study titled "Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy". 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 opio...
What is the current status of trial NCT07276906?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2026-01. Estimated completion is 2026-08.
What interventions are being tested in trial NCT07276906?
The interventions under investigation include: Ketorolac (DRUG), Fentanyl (DRUG), Nerve of Arnold Block (PROCEDURE), Sham Intramuscular Injection (PROCEDURE), Sham Nerve of Arnold Block (PROCEDURE).
Who is sponsoring clinical trial NCT07276906?
This trial is sponsored by University of South Alabama, which has 17 total clinical trials registered on ClinicalTrials.gov.
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