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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514642-37-00
Enrollment
150
Registered
2024-07-10
Start date
2020-01-31
Completion date
Unknown
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Detailed description

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, 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., 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), Bronchospasm/wheezing 1. Yes 2. No • In absence of a scale, 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, 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, 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

Interventions

DRUGMidazolam Rowa 2.5 mg oromucosal solution

Sponsors

UZ Brussel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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, 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., Respiratory postoperative complications Scored directly post-induction and post detubation - Laryngospasm: Four-point scale (17) 1. No Laryngospasm 2. Mild laryngospas

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026