The effect of tablet-multimedia versus midazolam medication on the level of preoperative anxiety in pediatric day-care.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004671-39-BE

Enrollment

150

Registered

2019-12-23

Start date

2020-01-28

Completion date

Unknown

Last updated

2024-07-15

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

Interventions

Trade Name: Apple Benelux BV Product Name: IPAD Pharmaceutical Form: Trade Name: Buccolam Pharmaceutical Form: Oromucosal solution INN or Proposed INN: MIDAZOLAM HYDROCHLORIDE CAS Number: 59467-96-8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 1 year and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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 ;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	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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 ;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

—

Secondary

Measure	Time frame
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 ;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 residen	—

Measure

Time frame

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 ;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 residen

—

Countries

Belgium

Contacts

Public ContactDepartement of Anesthesie

Universitair Ziekenhuis Brussel (UZ Brussel)

Virgini.vanbuggenhout@uzbrussel.be0032024749232

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026