Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
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- STATUS
- Recruiting
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- participants needed
- 150
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- sponsor
- Universitair Ziekenhuis Brussel
Summary
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.
Description
Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.
Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.
Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.
- Objective
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.
Details
| Condition | Tonsillectomy, Circumcision, Ambulatory Surgery, Dental Care, Preanesthetic Medication, inhalation anesthesia, Perioperative Anxiety |
|---|---|
| Age | 1years - 8years |
| Treatment | Midazolam oral solution, IPAD |
| Clinical Study Identifier | NCT04273035 |
| Sponsor | Universitair Ziekenhuis Brussel |
| Last Modified on | 16 February 2024 |
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