Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia (pediaPREM)

University Hospital Center (CHU)

Status and phase: Enrolling; Phase 3

Conditions: Anesthesia

Treatments: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05681572

2022-501124-23-00 (Other Identifier)

RECHMPL21_0354

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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
• Subjects who need to receive intravenous alpha agonist in perioperative
• Subjects requiring emergency intervention
• Subjects requiring preoperative hypnosis
• Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)
• Subject having had a surgical intervention in the month preceding the inclusion.
• Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)
• Subjects who are scheduled for surgery as part of oncology management
• Pregnant or breastfeeding woman
• Subject whose two parents have not signed a written informed consent
• Subjects who are not affiliated with or benefiting from a social security plan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 3 patient groups, including a placebo group

Premedication Group (Midazolam)

Experimental group

Description:

Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room

Treatment:

Drug: Midazolam

Premedication Group (Dexmedetomidine)

Experimental group

Description:

Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room

Treatment:

Drug: Dexmedetomidine

Placebo Group

Placebo Comparator group

Description:

grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room

Treatment:

Drug: Placebo