The effect of handheld-multimedia versus midazolam premedication on the level of perioperative anxiety in pediatric day-care. A randomized controlled trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

31 Jan 2020 → ongoing

Decision date (initial)

2024-07-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514642-37-00

EudraCT number

2019-004671-39

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The goal of this study is, first, to evaluate the need for midazolampremedication
in pediatric day-care patients induced by inhalational
anesthesia, and second, to compare the efficacy and safety between
anxiolysis by multimedia with an IPAD versus (no anxiolysis) and versus
anxiolysis by premedication with midazolam prior to anestheticinduction.
Our hypothesis is that Tablet/IPAD distraction could result in equal or
better anxiety control in comparison to the standard care with
midazolam-premedication.
The primary endpoint is reduction in level of anxiety perioperative,
primarily during induction in children between one and eight years of
age in day-care-surgery.

Secondary objectives 8

1. Anxiety reduction perioperative on daycare, holding and recovery
2. the incidence of stressful anesthetic mask-inductions
3. The incidence of laryngeal spasms or bronchospasm
4. Parental satisfaction
5. parental stress/anxiety level
6. Postoperative anxiety
7. Postoperative POCIS
8. RASS-score evaluation of sedation or possible negative behavior preoperative after midazolam administration

Conditions and MedDRA coding

Perioperative anxiety in children scheduled for an elective circumcision, dental care or tonsillectomy/adenoidectomy in day-care

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 1 year and <8 years old
2. ASA 1 or 2
3. Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
4. Written informed consent by the legal parents or caretaker

Exclusion criteria 14

1. Parents of the patient wish not to participate with the study
2. Parents are not able to give informed consent (language barrier, legally incapable)
3. A contraindication for the use of premedication with midazolam
4. A known allergy to midazolam
5. A contraindication for premedication in general
6. A contraindication for the use of a gas-induction/gas-anesthesia
7. A contraindication for the use of sevoflurane
8. A known mental retardation of the child
9. Preoperative behavioral disturbances and psychiatric disorders
10. Any use of psychoactive medication
11. A known photosensitive epilepsy
12. A previous operation within 3 months of the time of scheduled operation
13. Any other contraindication for the use of the study medication
14. Previous history of multiple surgery (>3)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoints are the difference in perioperative anxiety between the two groups measured with mYpas-score and parental-scoring with the 5-point anxiety scale.

Secondary endpoints 7

1. Stressful inductions (anesthetic satisfaction) Definition of stressful anesthetic inductions will be qualified by scaling and noted by the anesthesiologist, directly post-induction. XML File Identifier: Mmsidp0h9a5a/NwZENxH2Odvq/w= Page 15/25 1. Cooperative Smooth Induction: no crying, no unrest 2. Passive induction: crying, no unrest 3. Anxious induction: crying and unrest 4. Combative induction: total hysteric 2. Parental scoring for anxiety of the patient
2. Parental scoring for anxiety of the patient will be done by the following the 5-point anxiety scale used: 1. Happy (playing) 2. Happy/little worried (playing cautiously) 3. Worried (no playing, silently) 4. Anxious (crying) 5. Hysterical (crying and screaming) Parental scoring will be done, on the daycare preoperative, on the holding, postoperative on the recovery.
3. Respiratory postoperative complications Scored directly post-induction and post detubation - Laryngospasm: Four-point scale (17) 1. No Laryngospasm 2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen) 3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation) 4. Severe laryngospasm (relieved by succinylcholine and intubation)
4. Bronchospasm/wheezing 1. Yes 2. No • In absence of a scale
5. Parental Satisfaction on the anxiety-management perioperative: measured on holding, after induction, recovery, postop daycare unit. 1. Extremely satisfied 2. Satisfied 3. Neutral 4. Unsatisfied 5. Extremely Unsatisfactory
6. Postoperative POCIS-Score by leaving the recovery. POCIS is more suitable for young children then the traditional VAS-score (18) See Appendix III of the protocol
7. Preoperative sedation or negative behavior Evaluation of sedation or possible negative behavior preoperative after midazolam is done by the RASS-score. (19) See Appendix III of the protocol

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Virgini Van Buggenhout

Public contact point

Organisation

UZ Brussel

Contact name

Domien Vanhonacker

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications