The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery. Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery. This study is prospective and children will be randomized in one of the following arm: * Dexmedetomidine (experimental treatment) * Placebo The experimental treatment or placebo will be administrated at one time point at the time of incision. Participants and their legal representative will have to respond to questionnaires at several time points following the surgery: Day 1, Week 1, Month 3 and Month 6.
Postoperative pain, which can develop into chronic pain in children, can have a significant impact on the quality of life of the child and their parents. Management of acute postoperative pain is crucial to prevent chronic pain, and perioperative opioid sparing aims to reduce opioid side effects. The emergence of postoperative delirium (ED) is also a concern, as it can cause intense agitation and diagnostic difficulties. Dexmedetomidine, in addition to its sedative and analgesic effects, has been shown to prolong the duration and effectiveness of regional anesthesia (LAR), thereby reducing the need for opioids and attenuating the severity of postoperative delirium. Its use in these settings could improve pain management and reduce complications associated with pediatric surgery, thus offering a promising therapeutic option.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
The pain will be assessed on admission and every 15 minutes until discharge from the PACU
The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months
UH of Montpellier
Montpellier, France, France
RECRUITINGRescue analgesic
Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms.
Time frame: From the end of surgery to hospital discharge (up to 7 days)
Postoperative pain
Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home.
Time frame: From the end of surgery to hospital discharge (up to 2 days)
Intraoperative morphine consumption
Time frame: From anesthesia induction to the end of surgery (up to 24 hours)
Emergency analgesics
Dose in milligrams of emergency analgesics in the PACU
Time frame: From the end of surgery to hospital discharge (up to 24 hours)
Adverse events
Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting)
Time frame: From the end of surgery up to 7 postoperative days
Length of hospital stay
Length of hospital stay in hours from admission to discharge
Time frame: From the start of hospitalization to hospital discharge (up to 7 days)
Ped-PADSS score
The Post-Anesthetic Discharge Scoring System aimed to assess the possibility of discharge. The minimum is 0 and the maximum 10. A score of 9 or 10 authorizes hospital discharge.
Time frame: From the end of surgery to hospital discharge (up to 2 days)
Pediatric Anesthesia Emergence Delirium
Incidence of emergence of delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale. Score from 0 to 20, a score \> 9 indicates an emergence delirium
Time frame: From the end of surgery to hospital discharge (up to 24 hours)
Post-Hospitalization Behavior Questionnaire
Post-Hospitalization Behavior Questionnaire at day 1 and day 7. This questionnaire is composed of 27 items rated from 1 to 5, minimum score : 27, maximum score: 135. A score above 68 is associated with an increase in postoperative behavioral problems.
Time frame: From the end of surgery up to 6 postoperative months
Postoperative Pain Measure For Parents
Postoperative Pain Measure For Parents at 7 days, 3 and 6 months. Score: from 0 to 10 with 10 items. A score above 6 indicates significant pain.
Time frame: From the end of surgery up to 6 postoperative months
Post-operative quality of life questionnaire
Post-operative quality of life questionnaire pedsQL at 3 and 6 months. The 23 questions cover 4 different domains: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). The parent questionnaire assesses parents' perceptions of their child's health-related quality of life.
Time frame: From the end of surgery up to 6 postoperative months
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