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Trial record 24 of 415 for:    KETOROLAC

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

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ClinicalTrials.gov Identifier: NCT02653742
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Anica Crnkovic, Albany Medical College

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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Otitis Media Drug: Ketorolac Drug: Fentanyl Phase 4

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Toradol

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




Primary Outcome Measures :
  1. Pain score assessment [ Time Frame: Through study completion, an average of 1 hour postop ]
    Pain assessment score using CHEOPS


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   8 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653742


Contacts
Contact: Farzana Afroze, MD 518-262-4300 afrozef@mail.amc.edu
Contact: Anica Crnkovic, MD 518-262-4300 CrnkovA@mail.amc.edu

Locations
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Sponsors and Collaborators
Anica Crnkovic
Investigators
Principal Investigator: Anica Crnkovic, MD Albany Medical College

Publications:

Responsible Party: Anica Crnkovic, Anesthesiologist, Albany Medical College
ClinicalTrials.gov Identifier: NCT02653742     History of Changes
Other Study ID Numbers: 3943
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Pain, Postoperative
Otitis Media
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors