Preoperative Anxiety, Preoperative Anxiety Experienced by the Pediatric Patient
Conditions
Keywords
premedication, intranasal dexmedetomidine, intranasal midazolam, sedation, mask acceptance, Pediatric anesthesia
Brief summary
The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.
Interventions
DRUGDexmedetomidine + Midazolam 0.4 mg/kg
Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.
DRUGDexmedetomidine + Midazolam 0.2 mg/kg
Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to one of two treatment arms
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 1 to 8 years * Scheduled for elective surgery under general anesthesia * Surgery duration \< 1 hour * ASA physical status I or II * Parent or legal guardian able to provide informed consent
Exclusion criteria
* Refusal to participate by parent/guardian * Nasal infections, pathology, or epistaxis * Runny nose or upper respiratory tract infection * Hepatic Dysfunction or significant liver disease * Epilepsy * BMI \> 30 * Known allergy to dexmedetomidine or midazolam * Fever on day of surgery * Coagulopathy * Scheduled for cardiothoracic or neurosurgical procedures * Congenital heart disease * Neurological or mental disorders * Pre-existing sedation (MOASS \< 5) on the day of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mask Acceptance Score (MAS) at time of induction | At the time of induction (approximately 30 minutes after premedication) | Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Level (MOASS) at 15 and 30 minutes after premedication | 15 minutes and 30 minutes after drug administration | Sedation will be evaluated using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS). Scores will be recorded at 15 and 30 minutes after intranasal drug administration. |
| Child-Parent Separation Score | Approximately 30 minutes after premedication (at time of separation) | Measured using the Child-Parent Separation Scale at the time of separation from parents. Scores of 1 or 2 indicate satisfactory separation; score of 3 indicates poor separation. |
| Heart Rate | Baseline, 30minutes after medication and at the time of anesthesia induction. | Heart rate will be monitored at baseline, 30minutes after medication and at the time of anesthesia induction. Mean heart rate values will be compared between the two groups. |
| Blood Pressure | Baseline, 30minutes after medication and at the time of anesthesia induction. | Mean blood pressure will be monitored at baseline, 30minutes after medication and at the time of anesthesia induction. Mean blood pressure values will be compared between the two groups. |
| Time to Recovery (Modified Aldrete Score ≥ 9) | From cessation of inhalational anaesthesia until Modified Aldrete Score ≥9 is achieved. | The time from cessation of inhalational anaesthesia to achieving a Modified Aldrete Score of ≥9 will be recorded. |
| Time to Extubation | The time between the cessation of inhalational anesthesia and the removal of the endotracheal tube. | The time from the cessation of inhalational anesthesia and the removal of the endotracheal tube will be recorded. |
| Perioperative Adverse Events | From the time of drug administration until discharge from the Post-Anesthesia Care Unit (PACU) to the Ward | Incidence of adverse effects such as nasal irritation, Post Operative nausea\& vomiting will be recorded and compared between groups. |
Countries
Egypt
Outcome results
None listed