Supracondylar Humerus Fracture
Conditions
Keywords
Elbow surgery, Pain
Brief summary
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
Detailed description
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.
Interventions
DRUGAcetaminophen-Hydrocodone
Narcotic
Non-narcotic
Sponsors
The Campbell Foundation
Le Bonheur Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* isolated supracondylar humerus fracture * undergoing closed reduction with percutaneous pinning (CRPP)
Exclusion criteria
* Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone * Liver or renal disease * history of bleeding disorder * medical diagnosis of juvenile arthritis * on chronic NSAIDs or Opioids PRIOR to the procedure * medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma) * vascular compromise and/or compartment syndrome upon admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 24 hours (duration of post-operative stay) | Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Acetaminophen-Hydrocodone: Narcotic | 13 |
| Treatment Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Acetaminophen and Ibuprofen: Non-narcotic | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient discharged from PACU. No study meds adinistered | 0 | 1 |
| Overall Study | Standard of care orders entered by resident | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Treatment | Total |
|---|---|---|---|
| Age, Continuous | 6.8 Years STANDARD_DEVIATION 1.6 | 6.6 Years STANDARD_DEVIATION 0.92 | 6.7 Years STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 9 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Pain Scores
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Time frame: 24 hours (duration of post-operative stay)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain Scores | 0.95 score on a scale | Standard Deviation 1.35 |
| Treatment | Pain Scores | 0.97 score on a scale | Standard Deviation 1.53 |