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

Sponsor
Erzurum City Hospital
Study ID
NCT07622641
Status
Not Yet Recruiting

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Conditions

  • Adenotonsillectomy
  • Postoperative Pain
  • Preoperative Anxiety
  • Surgical Stress Response

Eligibility Criteria

Sex
ALL
Age
3 Years - 10 Years
Healthy Volunteers
Not accepted

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.
  • Midazolam (Intravenous) — DRUG
    Intravenous midazolam will be administered at a dose of 0.05-0.1 mg/kg during anesthesia induction.

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative Oral Midazolam
    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.
  • Experimental: Intraoperative Intravenous Midazolam
    Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg/kg during anesthesia induction.

Primary Outcome Measure

Change in Serum Cortisol Levels [ Time Frame: At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU) ]

Central Contacts

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