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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514550-73-00 | EU Trial (CTIS) Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision. |
|
| Placebo | Placebo Comparator | Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Intravenous administration of 1 µg /kg of dexmedetomidine in 10 ml of 0.9% sodium chloride at the time of incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rescue analgesic | Rescue analgesic (Nalbuphine, Nubain®) administration in the PACU between the 2 arms. | From the end of surgery to hospital discharge (up to 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the end of surgery to hospital discharge (up to 2 days) |
| Intraoperative morphine consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien PICO, MD | Contact | +33 7 88 01 44 14 | j-pico@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH of Montpellier | Recruiting | Montpellier | France | 34295 | France |
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| Placebo administration | Drug | Intravenous administration of 10 ml sodium chloride 0.9% at the time of incision |
|
| Face Legs Activity Cry Consolability scale | Other | The pain will be assessed on admission and every 15 minutes until discharge from the PACU |
|
| Post-Hospitalization Behavior Questionnaire | Other | The Post-Hospitalization Behavior Questionnaire will be completed at day 1 and at day 7 |
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| Postoperative pain measure | Other | The Postoperative pain measure will be completed by parents at day 1, day 7, 3 months and 6 months |
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| Post-operative quality of life questionnaire | Other | The Post-operative quality of life questionnaire pedQL will be completed at 3 and 6 months |
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| From anesthesia induction to the end of surgery (up to 24 hours) |
| Emergency analgesics | Dose in milligrams of emergency analgesics in the PACU | 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) | From the end of surgery up to 7 postoperative days |
| Length of hospital stay | Length of hospital stay in hours from admission to discharge | 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. | 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 | 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. | 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. | 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. | From the end of surgery up to 6 postoperative months |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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