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Elbow FractureNCT01328782

The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

A study testing Oxycodone with Acetaminophen, Bupivacaine 0.25% and Ropivacaine 0.20% in people with Elbow Fracture, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Elbow Fracture
What is being tested?
Oxycodone with Acetaminophen, Bupivacaine 0.25% and Ropivacaine 0.20%
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteUnited States
Study dates
Jun 2008to Jun 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.
  • Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
  • Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Children's Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read more

In this study, pain will be treated in one of the following ways:

  1. with oral pain medication
  2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or
  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.

The correct dosages of all drugs will be safely prescribed by the doctor on an individual basis and all drugs will be used under the careful watch of your attending physician. All the drugs used this study are approved by the FDA for use in adults but they are not specifically approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are not specifically approved by the FDA for use in children. All drugs used in this study will be used in a way that is considered to be safe and reasonable by the Children's Hospital.

Read the detailed description

Purpose: In recent years, despite the lack of consistent evidence, the use of intraarticular (into the joint)injections during ambulatory, orthopaedic surgery has become a popular strategy for reducing post-operative pain. In this randomized, single center, prospective study the investigators will evaluate the analgesic effectiveness of intraarticular injections of local anesthesia during the closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx) in children. In order to determine the efficacy of intraarticular injections, perceived post-operative pain will be compared among the three study groups receiving either a 0.25 % intraarticular injection of bupivacaine (Group 1 ), a 0.20% intraarticular injection of ropivacaine (Group 2) or no intraarticular injection (Control). All groups will receive the same post-operative oral pain medication of oxycodone (0.1 to 0.15 mg/kg) with acetaminophen.

Primary Aim(s) : Compare the primary and secondary pain outcomes variables in each of the three study groups.

  • The primary pain outcome variables are defined as the following:
  • Self-reported pain within 30-60 min. of arrival to the recovery room
  • Self-reported pain at two hours post-operative
  • The secondary pain outcome variables are defined as the following:
  • Parent perception of post-operative pain (scores of modified version of Foster and Varni's Total Quality of Pain Management Survey (TQPM) given in the first two hours after surgery)
  • Time t o first administration of oral pain medication
  • Total dose and frequency of oral pain medication taken during first 72 hours post-operative
  • Dose (per kg) of local anesthetic received intra-operatively
  • Total dosage of all intra-operative analgesics (in morphine equivalents)
  • Pre-operative The Faces Pain Scale-Revised (FSP-R) score

Hypotheses for Primary Aims:

  • There will not be a significant difference in any of the pain outcome variables amongst Groups 1 and 2.
  • There will be a statistically significant difference in each of the pain outcome variables when comparing; Group 1 and Control as well as Group 2 and Control.

Secondary Aim I: Evaluate the overall effect gender, ethnicity, age, American Society of Anesthesiologists (ASA) classification, fracture type and anesthesia time have on the pain outcome variables in this study population:

Hypotheses for Secondary Aim I: The investigators expect that age, gender, ASA classification, fracture type and anesthesia time will have a significant effect of on the primary and secondary pain outcome variables in this study population as a whole.

  • Participants aged 4-7 will be associated with more pain than participants aged 8-12 (increased selfreported pain scores, increased parent TQPM scores, decreased time to first administration of oral pain medication, increased total dosage of oral pain medication taken during first 72 hours post-operative, increased frequency of oral pain medication taken during first 72 hours post-operative).
  • Females will be associated with more pain than males (increased self-reported pain scores, increased parent TQPM scores, decreased time to first administration of oral pain medication, increased total dosage of oral pain medication taken during first 72 hours post-operative, increased frequency of oral pain medication taken during first 72 hours post-operative ) .
  • An ASA classification of III will be associated with more pain than a classification of I or II (increased self-reported pain scores, increased parent TQPM scores, decreased time to first administration of oral pain medication, increased total dosage of oral pain medication taken during first 72 hours post-operative, increased frequency of oral pain medication taken during first 72 hours post-operative),
  • A type III fracture type will be associated with more pain than a type I or II (increased selfreported pain scores, increased parent TQPM scores, decreased time to first administration of oral pain medication, increased total dosage of oral pain medication taken during first 72 hours post-operative, increased frequency of oral pain medication taken during first 72 hours post-operative).
  • An increase in anesthesia time will be associated with more pain . (increased self-reported pain scores, increased parent TQPM scores, decreased time to first administration of oral pain medication, increased total dosage of oral pain medication taken during first 72 hours post-operative, increased frequency of oral pain medication taken during first 72 hours post-operative).

Secondary Aim II: Evaluate the overall effect that gender, ethnicity, age, ASA classification (I, II or III),fracture type and anesthesia time have on the pain outcome variables in each of the study groups (Compare 1, 2 and Control to study population as a whole).

Hypotheses for Secondary Aim II: The investigators anticipate that there will be no group difference in the effects that age, gender, ASA classification, fracture type or anesthesia time have on the primary and secondary pain outcome variables.

Secondary Aim III: Compare Group 1 and Group 2 for a potential dose dependent relationship between reported pain outcome variables and total dose of intraarticular injection.

Hypotheses for Secondary Aim III: In both groups, the investigators anticipate there will be a non-significant association between an increased dose of local anesthetic and decreased post-operative FSP-R scores. There will not be any difference in the significance of this dose dependent relationship between Group I and Group 2.

Conditions
Elbow Fracture
Being tested
Oxycodone with Acetaminophen, Bupivacaine 0.25%, Ropivacaine 0.20%
Keywords
elbow fracture, supracondylar elbow fracture, elbow, fracture, pain management, pediatric
Medical subject headings
Elbow Fractures, Fractures, Bone, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone with AcetaminophenDrug

    Also called Percocet

    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.

  • Bupivacaine 0.25%Drug

    Also called Marcaine

    • 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
  • Ropivacaine 0.20%Drug

    Also called Naropin

    • 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
Study groups in NCT01328782
Study groupRoleWhat they receive
The group receiving oral pain medicineActive comparatorThis group will receive Oxycodone with Acetaminophen orally
Receives: Drug: Oxycodone with Acetaminophen
The group receiving bupivacaine and oral pain medicineActive comparatorThis group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
Receives: Drug: Bupivacaine 0.25%
The group receiving ropivacaine and oral pain medicineActive comparatorThis 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.
Receives: Drug: Ropivacaine 0.20%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  1. 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

    Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.

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

  2. Time (in Minutes) to First Narcotic Administration

    Measured: first 72 hours after surgery close time

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

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

  4. Need for IV Morphine of Fentanyl

    Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study startJun 2008
  3. Primary completionAug 2010
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328782
Sponsor's protocol ID
07-1190
Status last verified
Jun 2012
First submitted
22 Sep 2010
Last updated
23 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Oxycodone with Acetaminophen, Bupivacaine 0.25% and Ropivacaine 0.20% in people with Elbow Fracture, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10). (time frame: Will be obtained 30 - 60 minutes after arrival to the recovery room). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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