Management of Post-Tonsillectomy Pain in Pediatric Patients

NCT04551196 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 202002118
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Conditions

Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3

  The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.

  up to 3 days following consent

Secondary Outcomes (8)

• Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7

  3 separate individual days, will be completed days after the surgery

• Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7

  up to 7 days following consent

• Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7

  3 separate individual days, will be completed days after the surgery

• Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7

  up to 7 days following consent

• Number of Participants With Rescue Medication Usage Through POD 3

  up to 3 days following consent

Study Arms (2)

Alternating Regimen

ACTIVE COMPARATOR

A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.

Drug: Alternating Acetaminophen and Ibuprofen

Combined Regimen

ACTIVE COMPARATOR

A regimen of acetaminophen and ibuprofen dosed together every 6 hours.

Drug: Combined Acetaminophen and Ibuprofen

Interventions

Alternating Acetaminophen and Ibuprofen DRUG

Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.

Also known as: Alternating regimen

Alternating Regimen

Combined Acetaminophen and Ibuprofen DRUG

Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.

Also known as: Combined regimen

Combined Regimen

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age at time of enrollment
• Undergoing tonsillectomy with or without adenoidectomy
• Able to provide informed consent from parent or legal guardian
• Able to provide assent if subject is a minor of appropriate age

You may not qualify if:

• Allergy to acetaminophen or ibuprofen
• Inability for study participant to cooperate with pain assessments
• Known pregnancy
• Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (15)

• Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.

  PMID: 30798778 BACKGROUND

• Ingram DG, Friedman NR. Toward Adenotonsillectomy in Children: A Review for the General Pediatrician. JAMA Pediatr. 2015 Dec;169(12):1155-61. doi: 10.1001/jamapediatrics.2015.2016.

  PMID: 26436644 BACKGROUND

• National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/

  BACKGROUND

• Alvarez Palacios I, Gonzalez-Orus Alvarez-Morujo R, Alonso Martinez C, Ayala Mejias A, Arenas Britez O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the Technique? Indian J Otolaryngol Head Neck Surg. 2017 Jun;69(2):187-193. doi: 10.1007/s12070-017-1058-9. Epub 2017 Jan 16.

  PMID: 28607888 BACKGROUND

• Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27.

  PMID: 25241379 BACKGROUND

• Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19.

  PMID: 27647717 BACKGROUND

• Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.

  PMID: 25624387 BACKGROUND

• Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).

  BACKGROUND

• D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1472-6. doi: 10.1016/j.ijporl.2015.05.042. Epub 2015 Jul 2.

  PMID: 26164211 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

• Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.

  PMID: 20007794 BACKGROUND

• Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. doi: 10.1016/j.pain.2005.11.012. Epub 2006 Feb 9.

  PMID: 16480830 BACKGROUND

• Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006 Sep 1;74(5):793-8.

  PMID: 16970023 BACKGROUND

• Haynes RB, McKibbon KA, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2.

  PMID: 8709739 BACKGROUND

• Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y.

  PMID: 30572868 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Tonsillitis

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: David Leonard, MD, Principal Investigator
• Organization: Washington University School of Medicine

dsleonard@wustl.edu

314-454-2136

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, open-label, non-inferiority treatment pilot study

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 28, 2020
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-07

Locations

US (1)