" Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.
Overview
- Phase
- Phase 3
- Intervention
- Midazolam
- Conditions
- Anesthesia
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- EVANpedia Score
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject over 7 and under 18 years of age
- •Subjects who are scheduled for surgery
- •Subject who will be under general anesthesia
- •Subject able to complete a self-questionnaire in French
Exclusion Criteria
- •Subject who has already participated in the pediaPREM study
- •Subject with a treated anxiety disorder
- •Subject with cognitive disorders
- •Subject suffering from chronic pain (outside the operated area)
- •Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment
- •Subject suffering from mental retardation
- •Subjects receiving psychotropic treatment
- •Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)
- •Subject with a contra-indication to midazolam and its excipients
- •Subject with a contra-indication to dexmedetomidine and its excipients
Arms & Interventions
Premedication Group (Midazolam)
Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room
Intervention: Midazolam
Premedication Group (Dexmedetomidine)
Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room
Intervention: Dexmedetomidine
Placebo Group
grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room
Intervention: Placebo
Outcomes
Primary Outcomes
EVANpedia Score
Time Frame: from the day of surgery up to the day one after surgery
To evaluate patient experience of the perioperative and post-operative period
Secondary Outcomes
- VAS-anxiety Scores(from preoperative period up to 6 postoperative month)
- Postoperative waking delay(from the end of the surgery up to the exit of the recovery room)
- Modified Brice questionnaire Score(from the day of surgery up to 1 day)
- Post Hospitalization Behavior Scores(15 postoperative days)
- quality of life(6 postoperative months)
- neuropathic pain(6 postoperative month)
- FPS-r scores(from the end of the surgery up to 6 post-operative month)
- Quality of life PedsQL(Up to 6 months post-operatively)