Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04273035
Study type	Interventional
Source	Universitair Ziekenhuis Brussel
Contact	Alex Van Hoorn, MD
Phone	+32468187852
Email	Alex.VanHoorn@uzbrussel.be
Status	Recruiting
Phase	Phase 4
Start date	February 1, 2020
Completion date	February 28, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03266094` - A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy	N/A
Completed	`NCT02228135` - The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage	N/A
Completed	`NCT00662987` - Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy	N/A
Completed	`NCT00273754` - The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).	Phase 2
Recruiting	`NCT06122948` - Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events	Phase 3
Recruiting	`NCT03783182` - Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy	Phase 4
Completed	`NCT03793816` - Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial	N/A
Not yet recruiting	`NCT06359925` - Suprazygomatic Nerve Block in Tonsillectomy Patients	N/A
Recruiting	`NCT06079125` - PFDD Versus PFDRT in Chiari Decompression Surgery	N/A
Recruiting	`NCT01904461` - HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children	N/A
Not yet recruiting	`NCT00756873` - Etoricoxib in Ear Nose Throat Surgery	Phase 3
Recruiting	`NCT05600595` - The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children
Completed	`NCT02987985` - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy	Phase 3
Completed	`NCT04066829` - Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy	N/A
Recruiting	`NCT05158348` - A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine	Phase 3
Completed	`NCT01605903` - Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy	Phase 2
Enrolling by invitation	`NCT02444533` - EXPAREL® for Pain After Tonsillectomy	Phase 4
Recruiting	`NCT02829515` - Tonsil Surgery in Sweden: A National Quality Register
Not yet recruiting	`NCT03491085` - Role of Antibiotics Post Tonsillectomy	Phase 1/Phase 2
Recruiting	`NCT05270109` - Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms