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Completed

NCT Number: NCT04551196

Management of Post-Tonsillectomy Pain in Pediatric Patients

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.

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Key information

Conditions

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

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternating Acetaminophen and Ibuprofen

Drug

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

Other names: Alternating regimen

Combined Acetaminophen and Ibuprofen

Drug

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

Other names: Combined regimen

Primary outcomes

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

    Time frame: up to 3 days following consent

    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 outcomes

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

    Time frame: 3 separate individual days, will be completed days after the surgery

    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.

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

    Time frame: up to 7 days following consent

    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.

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

    Time frame: 3 separate individual days, will be completed days after the surgery

    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.

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

    Time frame: up to 7 days following consent

    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.

  5. Number of Participants With Rescue Medication Usage Through POD 3

    Time frame: up to 3 days following consent

    The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.

  6. Number of Participants With Rescue Medication Usage Through POD 7

    Time frame: up to 7 days following consent

    The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.

  7. Proportion of Subjects That Adhere to the Assigned Medication Regimen

    Time frame: up to 3 days following consent

    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.

  8. Adverse Events

    Time frame: up to 7 days following consent

    Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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