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Management of Post-Tonsillectomy Pain in Pediatric Patients

Primary Purpose

Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alternating Acetaminophen and Ibuprofen
Combined Acetaminophen and Ibuprofen
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 4 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Saint Louis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Alternating Regimen

Combined Regimen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of 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.

Secondary Outcome Measures

Proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 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.
Proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7
The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 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.
Proportion of Faces pain scores ≥8 on POD 1, 3, and 7
The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7
The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Rescue Medication Usage through POD 3
The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Rescue Medication Usage through POD 7
The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Proportion of subjects that adhere to the assigned medication regimen
Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Adverse Events
Incidence of adverse events

Full Information

First Posted
September 9, 2020
Last Updated
January 26, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04551196
Brief Title
Management of Post-Tonsillectomy Pain in Pediatric Patients
Official Title
Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Single-center, randomized, open-label, non-inferiority treatment pilot study
Masking
None (Open Label)
Masking Description
Open-label
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternating Regimen
Arm Type
Active Comparator
Arm Description
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Arm Title
Combined Regimen
Arm Type
Active Comparator
Arm Description
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Intervention Type
Drug
Intervention Name(s)
Alternating Acetaminophen and Ibuprofen
Other Intervention Name(s)
Alternating regimen
Intervention Description
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
Intervention Type
Drug
Intervention Name(s)
Combined Acetaminophen and Ibuprofen
Other Intervention Name(s)
Combined regimen
Intervention Description
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Primary Outcome Measure Information:
Title
Proportion of FLACC pain scores ≥7 from POD 1 through POD 3
Description
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.
Time Frame
up to 3 days following consent
Secondary Outcome Measure Information:
Title
Proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7
Description
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 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.
Time Frame
3 separate individual days, will be completed days after the surgery
Title
Proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7
Description
The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 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.
Time Frame
up to 7 days following consent
Title
Proportion of Faces pain scores ≥8 on POD 1, 3, and 7
Description
The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Time Frame
3 separate individual days, will be completed days after the surgery
Title
Proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7
Description
The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Time Frame
up to 7 days following consent
Title
Rescue Medication Usage through POD 3
Description
The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Time Frame
up to 3 days following consent
Title
Rescue Medication Usage through POD 7
Description
The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Time Frame
up to 7 days following consent
Title
Proportion of subjects that adhere to the assigned medication regimen
Description
Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Time Frame
up to 3 days following consent
Title
Adverse Events
Description
Incidence of adverse events
Time Frame
up to 7 days following consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 4 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Saint Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30798778
Citation
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.
Results Reference
background
PubMed Identifier
26436644
Citation
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.
Results Reference
background
Citation
National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/
Results Reference
background
PubMed Identifier
28607888
Citation
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.
Results Reference
background
PubMed Identifier
25241379
Citation
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.
Results Reference
background
PubMed Identifier
27647717
Citation
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.
Results Reference
background
PubMed Identifier
25624387
Citation
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.
Results Reference
background
Citation
Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).
Results Reference
background
PubMed Identifier
26164211
Citation
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.
Results Reference
background
PubMed Identifier
23881651
Citation
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.
Results Reference
background
PubMed Identifier
20007794
Citation
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.
Results Reference
background
PubMed Identifier
16480830
Citation
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.
Results Reference
background
PubMed Identifier
16970023
Citation
Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006 Sep 1;74(5):793-8.
Results Reference
background
PubMed Identifier
8709739
Citation
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. Erratum In: Lancet 1997 Apr 19;349(9059):1180.
Results Reference
background
PubMed Identifier
30572868
Citation
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.
Results Reference
background

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Management of Post-Tonsillectomy Pain in Pediatric Patients

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