The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
Condition: Elbow Fracture
MeSH terms: Pain, Postoperative; Fractures, Bone; Elbow Fractures
Study type: Interventional

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. 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.
    

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.
    

Intervention name(s): Oxycodone with Acetaminophen; Bupivacaine 0.25%; Ropivacaine 0.20%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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; 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
Other intervention name(s): Percocet; Marcaine; Naropin
Intervention MeSH terms: Acetaminophen; Oxycodone; Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: elbow fracture; supracondylar elbow fracture; elbow; fracture; pain management; pediatric