The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any - 16 |
| Updated: | 3/7/2019 |
| Start Date: | January 2014 |
| End Date: | November 2016 |
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications
for providing pain control in children with fractures or those who have surgery to correct
bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to
suggest that these types of medications can adversely affect bone healing in adult patients
with broken bones or those having spine fusion surgery. There is little data with regard to
how these medications effect bone healing in children. With this project, the investigators'
goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to
demonstrate that these medications adequately control pain in children with broken bones or
those who have had an osteotomy.
for providing pain control in children with fractures or those who have surgery to correct
bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to
suggest that these types of medications can adversely affect bone healing in adult patients
with broken bones or those having spine fusion surgery. There is little data with regard to
how these medications effect bone healing in children. With this project, the investigators'
goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to
demonstrate that these medications adequately control pain in children with broken bones or
those who have had an osteotomy.
Non-steroidal anti-inflammatory drugs (NSAIDs) are effective in controlling both
post-operative pain and pain associated with orthopaedic injuries, particularly in the
pediatric population. Additionally, use of NSAIDs for pain control in this setting avoids the
use of narcotic pain medications, the adverse effects of which are well known.
Recent research has suggested a possible association between use of NSAIDs and impaired
fracture healing in the skeletally mature, or adult, population. Several adult mammal studies
have demonstrated inhibition of bony repair with administration of NSAIDs. Yet, other adult
animal studies have failed to find the same effect. Clinical data in the adult population is
similarly conflicted, with some studies showing an inhibition of bone healing after posterior
spinal fusion, while a larger study found no correlation. The data investigating the effects
of NSAID use in adults after fracture or osteotomy is even less clear with some studies
demonstrating higher rates of non-union with NSAID administration and others finding no
significant effect on bone healing.
The research investigating these outcomes in the skeletally immature population is limited;
one study compared administration of ketorolac versus normal saline for 7, 14 and 21 days in
a juvenile rat model with a stabilized tibia fracture. They found no significant difference
in strength, stiffness or histological characteristics of fracture callus between the two
groups. Clinical retrospective studies of the pediatric population with regard to use of
NSAIDs after posterior spinal fusion have failed to reproduce findings of inhibitory effects
on bone healing. Similarly, two retrospective studies found no cases of delayed union or
non-union in pediatric patients who received perioperative ketorolac around the time of
operative fixation of fractures, or osteotomy. Given these results, the way in which and the
degree to which NSAIDs perturb the inflammatory mileu during the acute phase of healing is
potentially distinct from the effects on bone healing in the skeletally mature.
There have been no clinical prospective, randomized studies to evaluate the effect, if any,
that NSAIDs have on bone healing in the skeletally immature patient population. The
investigators hypothesize that NSAID administration in the acute phase of bone healing,
whether it be a fracture or osteotomy, will not result in delayed union or non-union as
compared to patients who take acetaminophen for pain control during this same time period.
post-operative pain and pain associated with orthopaedic injuries, particularly in the
pediatric population. Additionally, use of NSAIDs for pain control in this setting avoids the
use of narcotic pain medications, the adverse effects of which are well known.
Recent research has suggested a possible association between use of NSAIDs and impaired
fracture healing in the skeletally mature, or adult, population. Several adult mammal studies
have demonstrated inhibition of bony repair with administration of NSAIDs. Yet, other adult
animal studies have failed to find the same effect. Clinical data in the adult population is
similarly conflicted, with some studies showing an inhibition of bone healing after posterior
spinal fusion, while a larger study found no correlation. The data investigating the effects
of NSAID use in adults after fracture or osteotomy is even less clear with some studies
demonstrating higher rates of non-union with NSAID administration and others finding no
significant effect on bone healing.
The research investigating these outcomes in the skeletally immature population is limited;
one study compared administration of ketorolac versus normal saline for 7, 14 and 21 days in
a juvenile rat model with a stabilized tibia fracture. They found no significant difference
in strength, stiffness or histological characteristics of fracture callus between the two
groups. Clinical retrospective studies of the pediatric population with regard to use of
NSAIDs after posterior spinal fusion have failed to reproduce findings of inhibitory effects
on bone healing. Similarly, two retrospective studies found no cases of delayed union or
non-union in pediatric patients who received perioperative ketorolac around the time of
operative fixation of fractures, or osteotomy. Given these results, the way in which and the
degree to which NSAIDs perturb the inflammatory mileu during the acute phase of healing is
potentially distinct from the effects on bone healing in the skeletally mature.
There have been no clinical prospective, randomized studies to evaluate the effect, if any,
that NSAIDs have on bone healing in the skeletally immature patient population. The
investigators hypothesize that NSAID administration in the acute phase of bone healing,
whether it be a fracture or osteotomy, will not result in delayed union or non-union as
compared to patients who take acetaminophen for pain control during this same time period.
Inclusion Criteria:
- • Male aged 16 years or less or female aged 14 years or less
- Open physis on radiographs
- Fracture undergoing closed treatment or operative treatment or patient undergoing
elective osteotomy
Exclusion Criteria:
- • Regular use of NSAIDs
- Allergy to NSAIDs
- Inability to take breakthrough medications due side effects or allergy
- Systemic illness
- Renal impairment
- Liver disease
- Polytrauma
- Uncontrolled diabetes
- Regular use of corticosteroids
- History of any skeletal dysplasia
- History of neuromuscular disorder
- History of bleeding disorder
- History of liver disorder
- Pathologic fracture
- Closed physes
- Male greater than 16 years old
- Female greater than 14 years old
- Pregnant or possibly pregnant females based on report and last menstrual period
We found this trial at
1
site
Columbia, Missouri 65212
Principal Investigator: Daniel Hoernschemeyer, MD
Phone: 573-882-1351
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