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

A

Anica Crnkovic

Status and phase

Unknown
Phase 4

Conditions

Otitis Media
Pain, Postoperative

Treatments

Drug: Fentanyl
Drug: Ketorolac

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

8 months to 7 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 3 patient groups

Ketorolac
Experimental group
Description:
Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.
Treatment:
Drug: Ketorolac
Fentanyl
Experimental group
Description:
Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.
Treatment:
Drug: Fentanyl
Ketorolac and Fentanyl
Experimental group
Description:
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.
Treatment:
Drug: Fentanyl
Drug: Ketorolac

Trial contacts and locations

1

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Central trial contact

Anica Crnkovic, MD; Farzana Afroze, MD

Data sourced from clinicaltrials.gov

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