Ketorolac on Postoperative Pain Reduction in Pediatric Patients with Adenotonsillectomy

NCT05074056 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 31070
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain management in the pediatric patient undergoing tonsillectomy is challenging. Despite being used in many procedures for postoperative pain management, perioperative ketorolac usage in pediatric tonsillectomy surgery is very limited. A recent survey showed that only 8.2% of anesthesiologists use NSAIDS for perioperative management of children with OSA undergoing adenotonsillectomy. The investigators propose to conduct a prospective, randomized study to investigate the opioid-sparing effect of perioperative ketorolac in pediatric patients who undergo tonsillectomies.

Conditions

Adenotonsillar Hypertrophy; Obstructive Sleep Apnea; Sleep-Disordered Breathing; Acute Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain management

  Change in pain score using the Wong-Baker FACES Pain Rating Scale (0-10 scale with 0 being "no hurt" and 10 being "hurts worst") and 0-10 Numeric Pain Intensity Scale (0-10 scale with 0 being "no pain" and 10 being "Worst pain").

  two hours

Study Arms (2)

Ketorolac

EXPERIMENTAL

A double-blinded number of children will get one dose of intravenous 0.5 mg/kg (max dose 30mg) ketorolac intraoperatively.

Drug: Ketorolac

Placebo

PLACEBO COMPARATOR

A double-blinded number of children will get one dose of intravenous placebo intraoperatively.

Drug: Ketorolac

Interventions

Ketorolac DRUG

We will administer intraoperative ketorlac.

Ketorolac; Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adenotonsillar hypertrophy
• ASA II
• Otherwise healthy child

You may not qualify if:

• Child \< 3 years old and \> 12 years old
• Severe Obstructive sleep apnea
• Chronic Kidney disease
• Chronic Liver Disease

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

SSM Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Related Publications (13)

• Franz AM, Dahl JP, Huang H, Verma ST, Martin LD, Martin LD, Low DK. The development of an opioid sparing anesthesia protocol for pediatric ambulatory tonsillectomy and adenotonsillectomy surgery-A quality improvement project. Paediatr Anaesth. 2019 Jul;29(7):682-689. doi: 10.1111/pan.13662. Epub 2019 Jun 19.

  PMID: 31077491 BACKGROUND

• Tan GX, Tunkel DE. Control of Pain After Tonsillectomy in Children: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Sep 1;143(9):937-942. doi: 10.1001/jamaoto.2017.0845.

  PMID: 28662233 BACKGROUND

• Scalzitti NJ, Sarber KM. Diagnosis and perioperative management in pediatric sleep-disordered breathing. Paediatr Anaesth. 2018 Nov;28(11):940-946. doi: 10.1111/pan.13506. Epub 2018 Oct 3.

  PMID: 30281185 BACKGROUND

• Tang C, Xia Z. Dexmedetomidine in perioperative acute pain management: a non-opioid adjuvant analgesic. J Pain Res. 2017 Aug 11;10:1899-1904. doi: 10.2147/JPR.S139387. eCollection 2017.

  PMID: 28860845 BACKGROUND

• Gupta A, Bah M. NSAIDs in the Treatment of Postoperative Pain. Curr Pain Headache Rep. 2016 Nov;20(11):62. doi: 10.1007/s11916-016-0591-7.

  PMID: 27841015 BACKGROUND

• Cashman JN. The mechanisms of action of NSAIDs in analgesia. Drugs. 1996;52 Suppl 5:13-23. doi: 10.2165/00003495-199600525-00004.

  PMID: 8922554 BACKGROUND

• Vadivelu N, Chang D, Helander EM, Bordelon GJ, Kai A, Kaye AD, Hsu D, Bang D, Julka I. Ketorolac, Oxymorphone, Tapentadol, and Tramadol: A Comprehensive Review. Anesthesiol Clin. 2017 Jun;35(2):e1-e20. doi: 10.1016/j.anclin.2017.01.001. Epub 2017 Apr 14.

  PMID: 28526155 BACKGROUND

• Maslin B, Lipana L, Roth B, Kodumudi G, Vadivelu N. Safety Considerations in the Use of Ketorolac for Postoperative Pain. Curr Drug Saf. 2017;12(1):67-73. doi: 10.2174/1574886311666160719154420.

  PMID: 27440142 BACKGROUND

• Forrest JB, Heitlinger EL, Revell S. Ketorolac for postoperative pain management in children. Drug Saf. 1997 May;16(5):309-29. doi: 10.2165/00002018-199716050-00003.

  PMID: 9187531 BACKGROUND

• Forrest JB, Camu F, Greer IA, Kehlet H, Abdalla M, Bonnet F, Ebrahim S, Escolar G, Jage J, Pocock S, Velo G, Langman MJ, Bianchi PG, Samama MM, Heitlinger E; POINT Investigators. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. Br J Anaesth. 2002 Feb;88(2):227-33. doi: 10.1093/bja/88.2.227.

  PMID: 11883386 BACKGROUND

• Phillips-Reed LD, Austin PN, Rodriguez RE. Pediatric Tonsillectomy and Ketorolac. J Perianesth Nurs. 2016 Dec;31(6):485-494. doi: 10.1016/j.jopan.2015.02.005. Epub 2016 May 5.

  PMID: 27931700 BACKGROUND

• Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.

  PMID: 23881651 BACKGROUND

• Roberts C, Al Sayegh R, Ellison PR, Sedeek K, Carr MM. How Pediatric Anesthesiologists Manage Children with OSA Undergoing Tonsillectomy. Ann Otol Rhinol Laryngol. 2020 Jan;129(1):55-62. doi: 10.1177/0003489419874371. Epub 2019 Sep 5.

  PMID: 31801377 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective Randomized Study

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: February 8, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)