Anesthesia, Pediatric Surgery
Conditions
Keywords
loco-regional anesthesia, Pain, Emergence delirium
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision.
DRUGPlacebo administration
Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision
OTHERFace Legs Activity Cry Consolability scale
The pain will be assessed on admission and every 15 minutes until discharge from the PACU
OTHERPost-Hospitalization Behavior Questionnaire
The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7
OTHERPostoperative pain measure
The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months
OTHERPost-operative quality of life questionnaire
The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age 1 to 7 years old male or female * To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis * Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block * National health insurance coverage * Have obtained signed informed consent from holders of parental authority * American Society of Anesthesiology (ASA) score : 1-2 * French read, written and spoken by legal representatives
Exclusion criteria
* Patient under 1 or over 8 years old * Patients with allergies to local anesthetics * Patient with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone * Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies) * Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology. * Patients and/or parents who refused to participate in the study * Proven allergy or contraindication to dexmedetomidine or nalbuphine * Previous study participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue analgesic | From the end of surgery to hospital discharge (up to 7 days) | Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative morphine consumption | From anesthesia induction to the end of surgery (up to 24 hours) | — |
| Emergency analgesics | From the end of surgery to hospital discharge (up to 24 hours) | Dose in milligrams of emergency analgesics in the PACU |
| Adverse events | From the end of surgery up to 7 postoperative days | Incidence of opioid-related side effects (respiratory complications - postoperative nausea and vomiting) |
| Length of hospital stay | From the start of hospitalization to hospital discharge (up to 7 days) | Length of hospital stay in hours from admission to discharge |
| Postoperative pain | From the end of surgery to hospital discharge (up to 2 days) | 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. |
| Pediatric Anesthesia Emergence Delirium | From the end of surgery to hospital discharge (up to 24 hours) | 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 |
| Post-Hospitalization Behavior Questionnaire | From the end of surgery up to 6 postoperative months | 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. |
| Postoperative Pain Measure For Parents | From the end of surgery up to 6 postoperative months | 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. |
| Post-operative quality of life questionnaire | From the end of surgery up to 6 postoperative months | 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. |
| Ped-PADSS score | From the end of surgery to hospital discharge (up to 2 days) | 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. |
Countries
France
Contacts
Primary ContactJulien PICO, MD
Outcome results
None listed