E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perioperative anxiety in children scheduled for an elective circumcision, dental care or tonsillectomy/adenoidectomy in day-care |
|
E.1.1.1 | Medical condition in easily understood language |
Perioperative anxiety in children scheduled for an elective circumcision, dental care or tonsillectomy/adenoidectomy in day-care |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The goal of this study is, first, to evaluate the need for midazolam-premedication 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 anesthetic-induction. 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.
|
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare between both trial arms: - Anxiety reduction perioperative on daycare, holding and recovery - the incidence of stressful anesthetic mask-inductions - The incidence of laryngeal spasms or bronchospasm - Parental satisfaction - parental stress/anxiety level - Postoperative anxiety - Postoperative POCIS - RASS-score evaluation of sedation or possible negative behavior preoperative after midazolam administration
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 1 year and <8 years old - ASA 1 or 2 - Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care - Written informed consent by the legal parents or caretaker
|
|
E.4 | Principal exclusion criteria |
- Parents of the patient wish not to participate with the study - 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 - 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)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
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.
Perioperative anxiety The definition peri-anesthetic anxiety until gas-induction will be qualified by scaling using the Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF). The scale is derived from the mYPAS made more practical without any loss of significant clinical information regarding children’s preoperative anxiety. The mYPAS-SF will be scored by trained nurses and anesthesiologists. The mYPAS is validated for children between 1 and 15 years of age. (14) (15) (16) See APPENDIX II
There will be scored with mYPAS-SF on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake. A difference of >10 point would be stated as significant conform Marechal et al. (12)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
There will be scored with mYPAS-SF on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake. |
|
E.5.2 | Secondary end point(s) |
- Stressful inductions (anesthetic satisfaction) Definition of stressful anesthetic inductions will be qualified by scaling and noted by the anesthesiologist, directly post-induction.
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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
There will be scored on daycare preoperative and on the holding by the nurse, directly post-induction by the anesthetist or resident and postoperative on the recovery when fully awake. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as reaching the requirements of the power analysis. 75 patients per trial arm. 150 patients in total |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |