The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study

NCT02076321 | Completed Phase 4 Results

• 1 other identifier: 1207111
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.

Study Arms (2)

Acetaminophen

OTHER

control group

Drug: Acetaminophen

NSAID (Ibuprofen)

OTHER

Study group

Drug: Ibuprofen

Interventions

Acetaminophen DRUG

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).

Also known as: Tylenol

Acetaminophen

Ibuprofen DRUG

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.

Also known as: Advil, Motrin

NSAID (Ibuprofen)

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Daniel Hoernschemeyer
• Organization: University of Missouri, Department of Orthopaedics

hoernschemeyerd@health.missouri.edu

(573)882-1351

Study Officials

• Daniel G Hoernschemeyer, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 5, 2019
• Results First Posted: April 2, 2018

Record last verified: 2019-01

Locations

US (1)