Back to search results

Comparing Pain Control Methods for Children Undergoing Ear Surgery

This study is comparing different ways to manage pain after a common ear surgery called bilateral myringotomy with tube placement. Researchers want to see if a Nerve of Arnold Block (a shot of numbing medicine near a nerve in the ear) works better than or as well as the usual treatment, which is a combination of fentanyl (an opioid pain reliever) and ketorolac (an anti-inflammatory medicine). You might be able to join if you are between 6 months and 6 years old, are scheduled for this ear surgery, and are generally healthy. The main goal is to see how many children still have moderate-to-severe pain in the recovery room after surgery. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 300 participants. To ensure fair comparison, some participants will receive sham (inactive) injections or blocks to maintain blinding.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for pain from PACU admission to PACU discharge, which is up to 1 hour.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276906

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

Not Yet Recruiting
PHASE4Ages 6–6InterventionalTreatment
University of South Alabama
~300 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:FentanylKetorolacNerve of Arnold BlockSham Intramuscular InjectionSham Nerve of Arnold BlockDexmedetomidine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Moderate-to-Severe Pain (FLACC Score ≥4) During PACU Stay
Measured over From PACU admission to PACU discharge, up to 1 hour

Conditions

Postoperative Pain

Explore related trials

Post-Operative Pain

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Karthik Swamy, MD
[email protected]
251-471-7045
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Allergy to study medications (fentanyl, ketorolac, bupivacaine)

What this trial measures

  • Number of Participants with Moderate-to-Severe Pain (FLACC Score ≥4) During PACU StayFrom PACU admission to PACU discharge, up to 1 hour

    Number of participants experiencing at least one FLACC (Face, Legs, Activity, Cry, Consolability) scale score of 4 or greater during Post-Anesthesia Care Unit stay. FLACC is a validated behavioral pain assessment tool scored 0-10, with scores ≥4 indicating moderate-to-severe pain. FLACC scores assessed every 15 minutes during PACU stay.