MIDAZOLAM for Perioperative anxiety

Inclusion criteria

• {"criterion_text":"- Age ≥ 1 year and <8 years old"}
• {"criterion_text":"- ASA 1 or 2"}
• {"criterion_text":"- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care"}
• {"criterion_text":"- Written informed consent by the legal parents or caretaker"}

Exclusion criteria

• {"criterion_text":"- Parents of the patient wish not to participate with the study"}
• {"criterion_text":"- Any use of psychoactive medication"}
• {"criterion_text":"- A known photosensitive epilepsy"}
• {"criterion_text":"- A previous operation within 3 months of the time of scheduled operation"}
• {"criterion_text":"- Any other contraindication for the use of the study medication"}
• {"criterion_text":"- Previous history of multiple surgery (>3)"}
• {"criterion_text":"- Parents are not able to give informed consent (language barrier, legally incapable)"}
• {"criterion_text":"- A contraindication for the use of premedication with midazolam"}
• {"criterion_text":"- A known allergy to midazolam"}
• {"criterion_text":"- A contraindication for premedication in general"}
• {"criterion_text":"- A contraindication for the use of a gas-induction/gas-anesthesia"}
• {"criterion_text":"- A contraindication for the use of sevoflurane"}
• {"criterion_text":"- A known mental retardation of the child"}
• {"criterion_text":"- Preoperative behavioral disturbances and psychiatric disorders"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured using the mYPAS score and parental scoring with a 5-point anxiety scale (parental scoring categories defined elsewhere in the protocol)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Anesthesiologist-rated scale recorded immediately post-induction with categories: 1 Cooperative Smooth Induction; 2 Passive induction; 3 Anxious induction; 4 Combative induction. Also parental scoring for anxiety."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Parental 5-point anxiety scale applied at preoperative daycare, on the holding area, and postoperative recovery."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Laryngospasm scored on a four-point scale recorded directly post-induction and post-detubation with specified clinical interventions defining severity levels."}
• {"endpoint_text":"- Bronchospasm/wheezing 1. Yes 2. No • In absence of a scale","definition_or_measurement_approach":"Binary recording of bronchospasm/wheezing (Yes/No)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Parental satisfaction measured on a 5-point ordinal scale at multiple perioperative timepoints."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"POCIS score assessed at discharge from recovery; protocol appendix referenced for details."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"RASS score used to evaluate sedation or negative behavior preoperatively after midazolam administration; protocol appendix referenced for details."}

Belgium

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

10-07-2024

Processing Time Days

30

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium