Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

NCT03453541 | Terminated Phase 4 FDA Drug

• 1 other identifier: 4923
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double blinded study is designed to compare the bleeding rates of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients ages 2-18.

Conditions

Analgesic Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate requiring operative intervention

  Rebleeding rate requiring operative intervention measured by recording either yes or no the patient did or did not returned to the OR for bleeding related to recent tonsillectomy. Requiring operative intervention would be a worse outcome than not requiring operative intervention.

  2 weeks post-operative

Secondary Outcomes (5)

• PACU length of stay

  Immediately after operation

• Post-operative opioid dosage

  Immediately after operation

• Post-operative pain score

  Immediately after operation

• Presence of post-operative nausea/vomiting

  Immediately after operation

• Number of emergency room visits/admissions

  2 weeks post-operative

Study Arms (2)

Ketorolac Tromethamine

EXPERIMENTAL

This group receives Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.

Drug: Ketorolac Tromethamine

0.9% Normal Saline

PLACEBO COMPARATOR

This group will receive 0.9% Normal Saline solution 1ml/60kg up to 1ml IV bolus (an equivalent volume as per kg Ketorolac Tromethamine dose) at the completion of the tonsillectomy in the operating room.

Drug: 0.9% Normal Saline

Interventions

Ketorolac Tromethamine DRUG

Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.

Also known as: Toradol

Ketorolac Tromethamine

0.9% Normal Saline DRUG

0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.

Also known as: 0.9% Sodium Chloride

0.9% Normal Saline

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA physical status I to III, age of 2 years to 18 years old (inclusive) scheduled for elective tonsillectomy with or without adenoidectomy.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (29)

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MeSH Terms

Interventions

Ketorolac Tromethamine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Farzana Afroze, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: CRNAs, PACU nurses, and participants are all blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: November 21, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 15, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)