Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

Prospective, Randomized, Allocation-Concealed, Blinded Study Designed to Compare Ketorolac Sublingual and Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02653742

Enrollment

150

Registered

2016-01-12

Start date

2015-05-31

Completion date

2022-12-31

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media, Pain, Postoperative

Brief summary

The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (BMTs).

Detailed description

This prospective, randomized, allocation concealed blinded study is designed to compare ketorolac sublingual vs. fentanyl intranasal vs. the combination of these two medications for pain control after BMTs in children. Bilateral myringotomy and tube placement is an elective operation, mainly in the pediatric population.

Interventions

DRUGKetorolac

Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.

DRUGFentanyl

Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Months to 7 Years

Healthy volunteers

Inclusion criteria

* American Society of Anesthesiologist (ASA) I-II physical class * Scheduled for elective BMT * Mask induction of anesthesia

Exclusion criteria

* Allergy to any NSAIDs * Severe upper respirator infection * Severe asthma * Bleeding disorders * History of GI bleeding * Renal impairment * Scheduled for one-sided myringotomy and tube placement

Design outcomes

Primary

Measure	Time frame	Description
Pain score assessment	Through study completion, an average of 1 hour postop	Pain assessment score using CHEOPS

Secondary

Measure	Time frame	Description
Administration of additional pain medication	Through study completion, an average of 1 hour postop	The need for additional pain medication other than the study medication to control postoperative pain

Countries

United States

Contacts

Primary ContactFarzana Afroze, MD

afrozef@mail.amc.edu518-262-4300

Backup ContactAnica Crnkovic, MD

CrnkovA@mail.amc.edu518-262-4300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026