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

September 9, 2021 updated by: Anica Crnkovic

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score assessment
Time Frame: Through study completion, an average of 1 hour postop
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
Time Frame: Through study completion, an average of 1 hour postop
The need for additional pain medication other than the study medication to control postoperative pain
Through study completion, an average of 1 hour postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anica Crnkovic

Investigators

  • Principal Investigator: Anica Crnkovic, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 10, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3943

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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