Pediatric Disorder
Conditions
Keywords
non opioid, pain management, pediatric pain, pediatric pain management
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.
Interventions
DRUGAcetaminophen
administered alternatively with other drug
DRUGIbuprofen
administered alternatively with other drug
Sponsors
Baylor Scott and White Health
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. | 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. |
| Pain Visual Analog Scale (VAS) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Parent/ guardian adherence | 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. |
Countries
United States
Outcome results
None listed