Children's Mercy Hospital & Clinics
Kansas City, Missouri, 64108, United States
NCT Number: NCT06187584
This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.
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Notify Me5 year–9 year
All sexes
Interventional
Phase 4
Kansas City, Missouri, 64108, United States
Pain is variably managed in pediatric populations, particularly in the postoperative outpatient setting. The lack of data describing and supporting the safety and efficacy of the use of analgesic drugs in children is a major contributor to this problem. Postoperative prescription opioids have been associated with high rates of morbidity and mortality in children and identified as a pathway to future opioid abuse. With increasing public awareness regarding these issues surrounding opioid use and no evidence to support superior treatment outcomes in children with the use of opioids, there is a pressing need for data to guide healthcare providers in choosing analgesic drugs to treat postoperative pain in pediatric patients.
Prior studies have evaluated the use of nonopioid versus opioid analgesic drugs in the outpatient setting following pediatric ambulatory surgery. These studies found nonopioid analgesics, such as acetaminophen and ibuprofen, to be as equally effective as opioid analgesics, including morphine, codeine and oxycodone. Further, the use of nonopioid analgesics was associated with significantly fewer side effects. These findings imply that nonopioid analgesics may be a superior initial therapy following ambulatory surgery.
However, no study has evaluated the use of nonopioid versus opioid analgesic regimens in the outpatient setting following surgical fixation of supracondylar humerus fractures (SCHFS). SCHFs are the second most common fracture in children, often requiring urgent surgical intervention. Despite their frequency, there is no standard for postoperative outpatient pain management in the treatment of these injuries.
Almost all SCHFs can be described according to the Gartland classification. The Gartland classification delineates three types of SCHFs. Gartland type I fractures are nondisplaced and do not require surgical intervention, while Gartland type II fractures are angulated, but maintain an intact posterior cortex. These may or may not require surgical intervention. However, Gartland type III fractures are completely displaced with no posterior cortical contact and require surgical intervention with either closed reduction and percutaneous pinning (CRPP) or open reduction with percutaneous pinning (ORPP). This study will look at only Gartland type III SCHFs because they necessitate surgical intervention, most commonly CRPP.
Investigators hypothesize that there is no difference in daily pain levels for nonopioid analgesic regimens compared to opioid analgesic regimens in management of post-operative pain in the outpatient period following surgical fixation of Gartland type III supracondylar humerus fracture in children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hydrocodone/acetaminophen 0.15mg/kg PO q6
15mg/kg PO q6 hours
10mg/kg PO q6 hours
Time frame: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).
The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome.
Time frame: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention
Using the Likert scale 1-5, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators asked families to rate the satisfaction of their child's pain control daily for 5 days. The higher the number, the higher the satisfaction.
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participants' parent completed a survey asking the number of days of medication use
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participant completed a Yes/No survey asking if they experienced any of the following: Nausea, Vomiting, Constipation, Headache, Dizziness, Drowsiness, Rash, Other.
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participant completed a Yes/No survey asking if use of medication other than those indicated by their physician to control pain occured.
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participant completed a survey asking for numerical count of phone calls for pain rescue.
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participant completed survey asking for count of visits for pain rescue.
Time frame: Postoperative days 1-5
Survey for number of doses taken by participant each postoperative day 1-5
Time frame: First follow up visit, occurring approximately one week postoperatively.
Participant completed survey using 5 point Likert scale "very poorly", "poorly", "neutral", "well", "very well".
Very poorly = 1, Poorly = 2, Neutral = 3, Well = 4, Very well = 5
Time frame: First follow up visit, occurring approximately one week postoperatively.
Using the Likert scale, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators ask families to rate overall their satisfaction with their child's pain control in the first five days after surgery.
Children's Mercy Hospital Kansas City
Other
Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study
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