Effect of Ketorolac on Post Adenotonsillectomy Pain

NCT03467750 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00097738
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with obstructive sleep apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study group where they will receive ketorolac in addition to the standard of care treatment or will receive only the standard of care pain management. The researchers hypothesize that by administering ketorolac at the end of the procedure once hemostasis has been achieved, it will be possible to decrease the amount of morphine administered in the post-anesthesia care unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy and safety of the current standard post-operative analgesic regimen employed at the study institution, in which opioid analgesia currently plays a prominent role.

Conditions

Obstructive Sleep Apnea

Keywords

Adenotonsillectomy; Opioids; Post-surgical pain; Anesthesiology; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Post-Anesthesia Care Unit (PACU) Morphine Requirements

  The total postoperative morphine dosage required to achieve analgesia (defined as a Face, Legs, Activity, Cry, Consolability (FLACC) Scale score of less than 3) in children with obstructive sleep apnea undergoing adenotonsillectomy was compared between study arms to examine the effect of ketorolac administration.

  Until PACU discharge (up to 261 minutes)

Secondary Outcomes (4)

• Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score

  10 minutes post-op, 20 minutes post-op, PACU discharge (up to 261 minutes)

• Post-Anesthesia Care Unit (PACU) Recovery Time

  Until PACU discharge (up to 261 minutes)

• Number of Participants With Post-Tonsillectomy Bleeding

  Up to 14 days after surgery

• Pain Medication Administration

  Surgery through hospital discharge (up to post-operative day 2)

Study Arms (2)

Ketorolac

EXPERIMENTAL

Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved

Drug: Ketorolac; Drug: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure.

Drug: Standard of Care

Interventions

Ketorolac DRUG

Patients in this group will receive 0.5mg/kg of ketorolac, administered intravenously.

Also known as: Toradol

Ketorolac

Standard of Care DRUG

All patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered.

Also known as: Sojourn, Ultane, Diprivan, Decadron, Precedex, Zofran, Morphine

Ketorolac; Standard of Care

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of sleep disordered breathing or obstructive sleep apnea
• Children undergoing elective tonsillectomy or adenotonsillectomy at Children's Healthcare of Atlanta Egleston location
• Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

You may not qualify if:

• Known coagulation defect
• Patients on longstanding NSAID therapy
• Known renal impairment

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Childrens Healthcare of Atlanta, Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Standard of Care; Sevoflurane; Propofol; Calcium Dobesilate; Dexmedetomidine; Ondansetron; Morphine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Heterocyclic Compounds, 3-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Laura Gilbertson
• Organization: Emory University

laura.gilbertson@emory.edu

404-785-6670

Study Officials

• Laura Gilbertson, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The PACU nurses will be blinded to ketorolac administration, but will be informed of all other medications given. The PACU nurses will evaluate the patients using FLACC scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. Morphine will be administered to obtain a FLACC score of less than 3.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 16, 2018
• Study Start: July 19, 2018
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)