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NCT Number: NCT06505148

Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?

To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.

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Key information

Conditions

Pediatric Disorder Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baylor Scott & White Health Temple Market

Temple, Texas, 76508, United States

Location contact

Marlene T Porter, PhD

CONTACT

[email protected]

254-724-9069

About this study

The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age group: 3 years to 18 years
  • General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Exclusion criteria

  • Patients who are allergic to acetaminophen and/or ibuprofen
  • Patients being evaluated by SANE or evaluated for nonaccidental trauma
  • Patients admitted post-op

The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.

Treatment and study plan

Acetaminophen

Drug

administered alternatively with other drug

Ibuprofen

Drug

administered alternatively with other drug

Primary outcomes

  1. Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.

    Time frame: 24, 48, and 72 hours after surgery

    Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.

  2. Pain Visual Analog Scale (VAS)

    Time frame: 24, 48, and 72 hours after surgery

    This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.

  3. Numeric Pain Rating Scale (NPRS)

    Time frame: 24, 48, and 72 hours after surgery

    The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.

Secondary outcomes

  1. Parent/ guardian adherence

    Time frame: 72 hours after surgery

    Adherence will be assessed by asking the parent/guardian regarding their ability to follow pain regimen and the ease to follow the instructions.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Baylor Scott and White Health

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 22, 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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