Comparative study between the effect of pharmacological and non-pharmacological measures on preoperative anxiety in preschoolers undergoing outpatient surgeries

Not Applicable

• Conditions: Anxiety; Preoperative Period; E04.614

• Registration Number: RBR-4d9d42n
• Lead Sponsor: Casa de saúde assistência médica infantil de urgência

Brief Summary

Introduction: anxiety in children who will undergo surgical procedures is an occurrence described in the literature, which affects approximately 50% to 75% of children. Objectives: to compare the effect between preoperative presentation of a short film in cartoon format and the use of an oral midazolam solution, administered as preanesthetic medication, in reducing anxiety in the preoperative period of preoperative -schoolchildren submitted to circumcision surgeries. Patients and methods: clinical, controlled, prospective, randomized and blind trial, carried out in a pediatric hospital. After sample calculation, 180 children were recruited, divided equally between the three groups. Children were randomized into three groups: 1) Control group; 2) Group that used Midazolam Hydrochloride, oral solution; 3) Group that watched the video on the tablet. Preoperative anxiety was analyzed using the Yale Scale, the presence of delirium using the PAED Scale, and pain using the FLACC Scale. Results: preschoolers who watched the video were less anxious when compared to the group who received Midazolam (p-value = 0.027). Children who watched the video had lower PAED values ??when compared to the group that received Midazolam and the control group. (p-value <0.00001). A significant association was observed between the presence of anxiety and postoperative delirium in the three groups. The use of Midazolam increased hospital stay. Conclusion: the group that watched the video had lower levels of anxiety, less frequency of delirium and shorter hospital stay when compared to the group that used Midazolam Hydrochloride.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-05
• Study Start: 2023-02-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Patients who will undergo circumcision; aged between 2 and 7 years; with physical status according to the American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria

Patients with Autism Spectrum Disorder (ASD); Attention Deficit Hyperactivity Disorder (ADHD); Patients with a previous history of paradoxical effect of Midazolam or hypersensitivity to any of its components; patient with serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow; patients who use psychostimulant drugs or antidepressants
Serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.
Use of psychostimulant or antidepressant drugs

Study & Design

• Study Type: Intervention
• Study Design: Not specified