Timing Of Midazolam İn Children Undergoing Adenotonsillectomy: Effects On Stress, Cortisol, And Recovery

NCT07622641 | Not Yet Recruiting

• 1 other identifier: ECH-AR-MSO-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital. Midazolam is commonly used in pediatric patients to reduce anxiety and improve perioperative comfort. However, the optimal timing of its administration (before surgery or during anesthesia induction) remains unclear. This study aims to compare the effects of preoperative oral midazolam and intraoperative intravenous midazolam on stress response, behavioral outcomes, and recovery quality. Participants will be randomly assigned to one of two groups. In Group A, children will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery. In Group B, children will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction. The primary outcome of the study is the change in serum cortisol levels, which reflects the physiological stress response. Blood samples will be collected twice: once 10 minutes after anesthesia induction and once 15 minutes after surgery in the post-anesthesia care unit. In addition to cortisol levels, the study will assess preoperative anxiety using an observational anxiety scale, postoperative pain using a behavioral pain scoring system, and parental satisfaction using a standardized questionnaire. These measures aim to provide a comprehensive evaluation of the child's perioperative experience. The findings of this study may help determine the most effective timing of midazolam administration to reduce stress, improve recovery, and enhance overall patient and family satisfaction in pediatric surgical care.

Conditions

Adenotonsillectomy; Surgical Stress Response; Postoperative Pain; Preoperative Anxiety

Keywords

Midazolam; Pediatric Anesthesia; Adenotonsillectomy; Premedication Timing; Preoperative Anxiety; Cortisol Response; Postoperative Pain; Recovery Quality

Outcome Measures

Primary Outcomes (1)

• Change in Serum Cortisol Levels

  Serum cortisol levels will be measured to assess physiological stress response.

  At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU)

Secondary Outcomes (4)

• Preoperative Anxiety Level (mYPAS Score)

  During the preoperative period before anesthesia induction

• Postoperative Pain Score (FLACC Score)

  At 15 minutes postoperatively in the post-anesthesia care unit (PACU)

• Recovery Status (Modified Aldrete Score)

  Within the first 30 minutes postoperatively in the PACU

• Parental Satisfaction (PAPS Survey)

  Within 30 minutes after the child becomes clinically stable in the postoperative period

Study Arms (2)

Preoperative Oral Midazolam

EXPERIMENTAL

Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg, administered 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration and improve tolerance.

Drug: Midazolam (Oral)

Intraoperative Intravenous Midazolam

EXPERIMENTAL

Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg/kg during anesthesia induction.

Drug: Midazolam (Intravenous)

Interventions

Midazolam (Oral) DRUG

Oral midazolam will be administered at a dose of 0.5 mg/kg, 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration.

Preoperative Oral Midazolam

Midazolam (Intravenous) DRUG

Intravenous midazolam will be administered at a dose of 0.05-0.1 mg/kg during anesthesia induction.

Intraoperative Intravenous Midazolam

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-10 years,
• Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy,
• American Society of Anesthesiologists (ASA) physical status I-II,
• Written informed consent obtained from parents or legal guardians

You may not qualify if:

• Children younger than 3 years or older than 10 years,
• American Society of Anesthesiologists (ASA) physical status greater than II,
• Known allergy to apple or apple-derived products,
• Known allergy or hypersensitivity to benzodiazepines,
• Presence of developmental delay,
• History of neuropsychiatric disorders,
• Current or recent use of corticosteroids,
• Expected or actual surgical duration longer than 90 minutes,
• Refusal of participation by parents or legal guardians

Sponsors & Collaborators

• Erzurum City Hospital: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mehmet Sercan Orbak, MD

  Erzurum City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Sercan Orbak, MD

CONTACT

+ 90 (506) 288 35 34; sercanorbak@gmail.com

Ahmet Ergün, MD

CONTACT

draergn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist (MD), Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups based on the timing of midazolam administration (preoperative oral vs intraoperative intravenous). Randomization will be performed using a computer-generated sequence with sealed envelope allocation. Each participant will receive only one intervention, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)