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
Who is this study for? Patients with Postoperative Pain, Otitis Media
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 7
Healthy Volunteers: f
View:
• American Society of Anesthesiologist (ASA) I-II physical class
• Scheduled for elective BMT
• Mask induction of anesthesia
Locations
United States
New York
Albany Medical Center
RECRUITING
Albany
Contact Information
Primary
Farzana Afroze, MD
afrozef@mail.amc.edu
518-262-4300
Backup
Anica Crnkovic, MD
CrnkovA@mail.amc.edu
518-262-4300
Time Frame
Start Date: 2015-05
Completion Date: 2022-12
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Anica Crnkovic