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

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

NCT02653742

3943

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