AnesthesiaPhase 3pediaPREMNCT05681572
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
A Phase 3 study testing Midazolam and Dexmedetomidine in people with Anesthesia, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Midazolam and Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2023to 18 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, Montpellier, 34295
Sophie BRINGUIER, PHARM D, phD, 0467338661 ext. +33, s-bringuierbranchereau@chu-montpellier.fr
About this study
Official title: " Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.
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.
Read the 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
- Conditions
- Anesthesia
- Being tested
- Midazolam, Dexmedetomidine, Placebo
- Keywords
- children premedication, anesthesia, children perioperative experience, anxiety, sedation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.
DexmedetomidineDrug
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.
PlaceboDrug
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.
| Study group | Role | What they receive |
|---|---|---|
| Premedication Group (Midazolam) | Experimental | Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room Receives: Drug: Midazolam |
| Premedication Group (Dexmedetomidine) | Experimental | Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room Receives: Drug: Dexmedetomidine |
| Placebo Group | Placebo comparator | grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVANpedia Score
To evaluate patient experience of the perioperative and post-operative period
Measured: from the day of surgery up to the day one after surgery
Secondary outcomes (8)
VAS-anxiety Scores
To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS)
Measured: 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
Measured: from the end of the surgery up to the exit of the recovery room
Modified Brice questionnaire Score
To evaluate postoperative amnesia after anesthesia
Measured: from the day of surgery up to 1 day
Post Hospitalization Behavior Scores
To evaluate changes of behavioral (appetite, sleep, sociability) after surgery
Measured: 15 postoperative days
quality of life
to evaluate the impact of the perioperative experience on the long-term experience
Measured: 6 postoperative months
neuropathic pain
to evaluate the percentage of patients with long-term neuropathic pain
Measured: 6 postoperative month
FPS-r scores
To evaluate the Postoperative level of pain thanks to the Faces Pain Scale-revised (FPS-r)
Measured: 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).
Measured: Up to 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start18 Apr 2023
- Primary completion18 Oct 2027 (estimated)
- Study completion18 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DADURE, PHD, Study director, Hospital of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681572
- Sponsor's protocol ID
- RECHMPL21_0354
- Other IDs
- 2022-501124-23-00
- Acronym
- pediaPREM
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No