Post Tonsillectomy Emergence Agitation
Conditions
Keywords
agitation, tonsillectomy, pediatric
Brief summary
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.
Interventions
DRUGMelatonin
Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
DRUGPlacebo
Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I or II. * Parent/legal guardian provides written informed consent
Exclusion criteria
* • Known allergy or contraindication to melatonin. * Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD). * Children receiving any sedative or psychoactive medication within 48 hours of surgery. * Emergency surgery or any procedure other than tonsillectomy/adenoidectomy. * Children with known sleep disorders or those taking melatonin supplements. * Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively. * Hepatic or renal dysfunction (ALT/AST \>2×ULN, Cr \>1.5 mg/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale | 5, 10, 15, and 30 minutes after arrival in the PACU. | The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge | 10-30 min from arriving to PACU | Measured as the time from PACU arrival to achieving a modified Aldrete score (a 10-point system used in the post-anesthesia care unit (PACU) to assess a patient's recovery and determine if they are ready for discharge. It evaluates five categories: Activity, Respiration, Circulation, Consciousness, and Oxygen saturation. Each category is scored from 0 to 2, and a total score of 9 or 10 generally indicates that the patient can be safely discharged from the PACU). ≥9 (min), |
| Postoperative Pain | first 2 hours postoperative | Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at the same time points as the PAED scale. |
| Rescue Analgesia | 24 hours after surgery | Total dose of rescue analgesia (e.g., intravenous morphine or fentanyl measured according to the child weight in kg ) required in the PACU. |
| Adverse Events | first 24-hour post operative | Incidence of PONV, respiratory depression (defined as {SpO}\_2 \< 90% requiring intervention), bradycardia (\<60 bpm), intraoperative hemodynamic instability excessive sedation (Ramsay Sedation Scale \> 3) and other adverse events. |
| Parent/caregiver satisfaction | first 24-hour post operative | measured at discharge (Likert scale) used to measure attitudes, opinions, and behaviors by asking respondents to rate their level of agreement or intensity of feeling regarding a statement, it include options such as strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree |
Countries
Egypt
Outcome results
None listed