Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen
- Conditions
- Pediatric Disorder
- Sponsor
- Baylor Research Institute
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain Visual Analog Scale (VAS)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Marlene Porter
Principal Investigator
Baylor Research Institute
Eligibility Criteria
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.
Arms & Interventions
Group A
Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
Intervention: Acetaminophen
Group A
Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.
Intervention: Ibuprofen
Group B
Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
Intervention: Acetaminophen
Group B
Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.
Intervention: Ibuprofen
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Parent/ guardian adherence(72 hours after surgery)