The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

NCT01328782 | Completed Results

• 1 other identifier: 07-1190
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare different ways of treating pain after surgery. This research study involves subjects who have a supracondylar elbow fracture and need surgery. This type of fracture occurs when the humerus (upper arm bone) is broken just above the elbow. Like any other surgery, you can expect that you will feel pain in the hours or days after the operation. Currently, despite the common occurrence of this surgery, there is not a standard way to treat and or prevent any of the pain afterwards. At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after this surgery. In this study, pain will be treated in one of the following ways:

1. 1.with oral pain medication
2. 2.with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or
3. 3.with oral pain medicine and an intraarticular shot of ropivacaine (another "numbing" drug). The shots will be given during surgery. Your participation will help us find out which of these three pain control methods works the best.

Conditions

Elbow Fracture

Keywords

elbow fracture; supracondylar elbow fracture; elbow; fracture; pain management; pediatric

Outcome Measures

Primary Outcomes (1)

• The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).

  The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

  Will be obtained 30 - 60 minutes after arrival to the recovery room

Secondary Outcomes (4)

• Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting

  Will be obtained from parent(s) 120 minutes after arrival to the recovery room

• Time (in Minutes) to First Narcotic Administration

  first 72 hours after surgery close time

• Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge

  Analgesic data collected during first four hours following the end of surgery (surgery close)

• Need for IV Morphine of Fentanyl

  First 120 minutes after the end of surgery (surgery close time)

Study Arms (3)

The group receiving oral pain medicine

ACTIVE COMPARATOR

This group will receive Oxycodone with Acetaminophen orally

Drug: Oxycodone with Acetaminophen

The group receiving bupivacaine and oral pain medicine

ACTIVE COMPARATOR

This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.

Drug: Bupivacaine 0.25%

The group receiving ropivacaine and oral pain medicine

ACTIVE COMPARATOR

This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.

Drug: Ropivacaine 0.20%

Interventions

Oxycodone with Acetaminophen DRUG

0.1- 0.15 mg/kg (oxycodone) every 4-6 hours as needed. Pills: 325 mg acetaminophen: 5 mg oxycodone per tablet. Liquid: 325 mg acetaminophen:5 mg oxycodone per 5 mL.

Also known as: Percocet

The group receiving oral pain medicine

Bupivacaine 0.25% DRUG

* Up to 4 ml at 0.25 % given to .. In toxic doses can lead to irregular heart beat, patients aged 4-7 (dose will be irregular heart rate and cardiac arrest. (This no greater than 0.71 mg/kg) * Up to 5 ml at 0.25 % by volume solution will be given to patients aged 8-12 (dose will be no greater than 0.63 mg/kg) * All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg

Also known as: Marcaine

The group receiving bupivacaine and oral pain medicine

Ropivacaine 0.20% DRUG

* Up to 4 ml at 0.20 % given to patients aged 4-7 (dose will be no greater than 0.57 mg/kg) * Up to 5 ml at 0.20 % by volume solution will be given to patients aged 8-1(dose will be no greater than 0.50 mg/kg) * All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg

Also known as: Naropin

The group receiving ropivacaine and oral pain medicine

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA class I, II or III
• Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
• Patients able to understand and report their pain with the Faces Pain Scale Revised

You may not qualify if:

• Medical contraindications to analgesic therapy.
• Known allergy or sensitivity to analgesic agent.
• Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
• Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
• Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
• Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
• Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
• For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
• Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
• Known drug allergy to oxycodone and or acetaminophen.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Elbow Fractures; Fractures, Bone; Agnosia

Interventions

Oxycodone; Acetaminophen; oxycodone-acetaminophen; Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Gaia Georgopoulos, MD
• Organization: Children's Hospital Colorado

Gaia.Georgopoulos@childrenscolorado.org

720-777-2588

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: April 5, 2011
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 23, 2015
• Results First Posted: June 13, 2012

Record last verified: 2012-06

Locations

US (1)