Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328782
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2010-09-22
Brief Title:
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Childrens Hospital
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 Childrens Hospital
Detailed Description:
Purpose In recent years despite the lack of consistent evidence the use of intraarticular into the jointinjections 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 025 intraarticular injection of bupivacaine Group 1 a 020 intraarticular injection of ropivacaine Group 2 or no intraarticular injection Control All groups will receive the same post-operative oral pain medication of oxycodone 01 to 015 mgkg with acetaminophen
Primary Aims 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 Varnis 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 IIIfracture 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
Primary Aims 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 Varnis 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 IIIfracture 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None