Trial Outcomes & Findings for The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study (NCT NCT02076321)
NCT ID: NCT02076321
Last Updated: 2019-03-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Acetaminophen
control group
Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).
|
NSAID (Ibuprofen)
Study group
Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
46
|
49
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study
Baseline characteristics by cohort
| Measure |
Acetaminophen
n=46 Participants
control group
Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).
|
NSAID (Ibuprofen)
n=49 Participants
Study group
Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.44 years
n=5 Participants
|
7.67 years
n=7 Participants
|
7.56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.Outcome measures
| Measure |
Acetaminophen
n=51 Participants
control group
Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).
|
NSAID (Ibuprofen)
n=51 Participants
Study group
Ibuprofen: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
|
|---|---|---|
|
Compare the Time to Union of Fractures and Osteotomies in Skeletally Immature Patients Administered NSAIDs for Pain Control, Versus Those Administered Acetaminophen for Pain Control.
|
41.2 Days
Interval 22.0 to 84.0
|
40.5 Days
Interval 19.0 to 98.0
|
Adverse Events
Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NSAID (Ibuprofen)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel Hoernschemeyer
University of Missouri, Department of Orthopaedics
Phone: (573)882-1351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place