Recruiting

Ketorolac vs. Fentanyl

Sponsor:

Anica Crnkovic

Code:

NCT02653742

Conditions

Pain, Postoperative

Otitis Media

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Fentanyl

Study Details

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).

Conditions

Pain, Postoperative

Otitis Media

Study ID

NCT02653742

Start date

May, 2015

Status verified date

Sep, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketorolac

Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.

experimental: Fentanyl

Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

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.

Interventions

Ketorolac

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

Fentanyl

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

Primary outcome measure

  • Pain score assessment [ Time Frame: Through study completion, an average of 1 hour postop ]

Central Contacts and Locations

Central contacts

Farzana Afroze, MD

518-262-4300afrozef@mail.amc.edu

Anica Crnkovic, MD

518-262-4300CrnkovA@mail.amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

More Information

Sponsor

Anica Crnkovic

Last update posted

Sep 13, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anica Crnkovic on 2021-09-13.