About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age group: 3 years to 18 years
General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)
Disqualifiers
Patients who are allergic to acetaminophen and/or ibuprofen
Patients being evaluated by SANE or evaluated for nonaccidental trauma
Patients admitted post-op
Trial design
Parallel
Treatments tested in this trial
Acetaminophen
Drugadministered alternatively with other drug
Ibuprofen
Drugadministered alternatively with other drug
Treatment groups
Trial outcomes
Primary outcomes
Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
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.
Pain Visual Analog Scale (VAS)
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.
Numeric Pain Rating Scale (NPRS)
The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.
Secondary outcomes
Parent/ guardian adherence
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 contacts
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Baylor Research Institute
Lead sponsor
Baylor Scott and White Health
Collaborator
This trial is not recruiting at the moment. You can still explore other options: