2024-514642-37-00招募中4 期
The effect of handheld-multimedia versus midazolam premedication on the level of perioperative anxiety in pediatric day-care. A randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Brussel
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 1 year and <8 years old
- •Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- •Written informed consent by the legal parents or caretaker
排除标准
- •Parents of the patient wish not to participate with the study
- •Any use of psychoactive medication
- •A known photosensitive epilepsy
- •A previous operation within 3 months of the time of scheduled operation
- •Any other contraindication for the use of the study medication
- •Previous history of multiple surgery (>3)
- •Parents are not able to give informed consent (language barrier, legally incapable)
- •A contraindication for the use of premedication with midazolam
- •A known allergy to midazolam
- •A contraindication for premedication in general
- •A contraindication for the use of a gas-induction/gas-anesthesia
- •A contraindication for the use of sevoflurane
- •A known mental retardation of the child
- •Preoperative behavioral disturbances and psychiatric disorders
结局指标
主要结局
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.
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.
次要结局
- 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
- Bronchospasm/wheezing 1. Yes 2. No • In absence of a scale
- 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)
- 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
研究者
Virgini Van Buggenhout
Scientific
UZ Brussel
研究点 (1)
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