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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Otitis Media

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use. | Drug: Ketorolac<br>* Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.<br>* Other names: Toradol;|
| Experimental: Fentanyl<br>Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use. | Drug: Fentanyl<br>* Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia<br>|
| Experimental: Ketorolac and Fentanyl<br>Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use. | Drug: Ketorolac<br>* Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.<br>* Other names: Toradol;Drug: Fentanyl<br>* Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessment | Pain assessment score using CHEOPS | Through study completion, an average of 1 hour postop | 

Secondary Outcome Measures

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