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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501124-23-00 | Other Identifier | EU CT (European Regulation No. 536/2014) |
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Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old.
The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.
Surgery is a stressful experience in children with preoperative and postoperative anxiety.
For preschooler undergoing surgery, anxiety is the highest in the preoperative period.
Most of studies have been conducted on young children (< 7yrs old) to show the relationship between preoperative anxiety and emergence of delirium and postoperative maladaptive behavioral changes.
Sedative and anxiolytic medication is frequently used in children to reduce anxiety and postoperative maladaptive experiences. Nevertheless, little clinical evidence supports is benefit for children older than 7 years.
Treating anxiety is not necessarily associated with better experience in all children because premedication causes postoperative sedation, amnesia and cognitive impairment.
The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience using self-report questionnaire.
Patients are randomized to 2 groups to received pharmacologic premedication or placebo.
For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premedication Group (Midazolam) | Experimental | Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room |
|
| Premedication Group (Dexmedetomidine) | Experimental | Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room |
|
| Placebo Group | Placebo Comparator | grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EVANpedia Score | To evaluate patient experience of the perioperative and post-operative period | from the day of surgery up to the day one after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| VAS-anxiety Scores | To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS) | from preoperative period up to 6 postoperative month |
| Postoperative waking delay | Time to wake up after surgery (minutes) to evaluate the delay emergence from anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie BRINGUIER, PHD | Contact | 0467338661 | +33 | s-bringuierbranchereau@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe DADURE, PHD | Hospital of Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uhmontpellier | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Patients are randomized to 2 groups to received pharmacologic premedication or placebo.
For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine (2 sup-groups).
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Physicians, the nurse responsible for administration, the staff following the patient and the patient will be blinded to randomisation.
Only the nurse involved in the preparation of experimental treatments is not blinded. She will not be involved in the follow-up of the study.
| Dexmedetomidine | Drug | 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse. |
|
| Placebo | Drug | 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse. |
|
| from the end of the surgery up to the exit of the recovery room |
| Modified Brice questionnaire Score | To evaluate postoperative amnesia after anesthesia | from the day of surgery up to 1 day |
| Post Hospitalization Behavior Scores | To evaluate changes of behavioral (appetite, sleep, sociability) after surgery | 15 postoperative days |
| quality of life | to evaluate the impact of the perioperative experience on the long-term experience | 6 postoperative months |
| neuropathic pain | to evaluate the percentage of patients with long-term neuropathic pain | 6 postoperative month |
| FPS-r scores | To evaluate the Postoperative level of pain thanks to the Faces Pain Scale-revised (FPS-r) | from the end of the surgery up to 6 post-operative month |
| Quality of life PedsQL | The quality of life will be measured by PedsQL in order to evaluate the impact of the perioperative experience on the long-term experience. 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. On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). | Up to 6 months post-operatively |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |