Timing Of Midazolam İn Children Undergoing Adenotonsillectomy: Effects On Stress, Cortisol, And Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorErzurum City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Midazolam (Oral)
DrugOral 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)
DrugIntravenous midazolam will be administered at a dose of 0.05-0.1 mg/kg during anesthesia induction.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Preoperative Oral MidazolamExperimental treatment 1 intervention
Group B: Intraoperative Intravenous MidazolamExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Serum Cortisol Levels
Serum cortisol levels will be measured to assess physiological stress response.
Time frame
At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU)Secondary outcomes
1
Preoperative Anxiety Level (mYPAS Score)
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (mYPAS), an observational tool evaluating behavioral anxiety in children across multiple domains. Scores will be normalized to a 0-100 scale, with higher scores indicating greater anxiety.
Time frame
During the preoperative period before anesthesia induction2
Postoperative Pain Score (FLACC Score)
Postoperative pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, a validated behavioral pain assessment tool for pediatric patients. Each category is scored from 0 to 2, with a total score ranging from 0 to 10, where higher scores indicate more severe pain.
Time frame
At 15 minutes postoperatively in the post-anesthesia care unit (PACU)3
Recovery Status (Modified Aldrete Score)
Recovery status will be assessed using the Modified Aldrete Score, which evaluates activity, respiration, circulation, consciousness, and oxygen saturation. Higher scores indicate better recovery and readiness for discharge from the PACU.
Time frame
Within the first 30 minutes postoperatively in the PACU4
Parental Satisfaction (PAPS Survey)
Parental satisfaction will be evaluated using the Pediatric Anesthesia Parent Satisfaction (PAPS) survey, a structured questionnaire assessing satisfaction with perioperative care, including communication, pain management, and overall experience. Scores range from 5 to 25, with higher scores indicating greater satisfaction.
Time frame
Within 30 minutes after the child becomes clinically stable in the postoperative periodSponsors and contacts
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Source ClinicalTrials.gov
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