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

NCT07622641 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-10

No results posted yet for this study

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
  • Preoperative Anxiety
  • Surgical Stress Response
  • Postoperative Pain

Interventions

DRUG

Midazolam (Oral)

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.

DRUG

Midazolam (Intravenous)

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

Sponsors & Collaborators

  • Erzurum City Hospital

    lead OTHER

Principal Investigators

  • Mehmet Sercan Orbak, MD · Erzurum City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2027-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622641 on ClinicalTrials.gov