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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group M (Melatonin Group) | Active Comparator |
| |
| Group P (Placebo Group) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 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, |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale | 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 | 5, 10, 15, and 30 minutes after arrival in the PACU. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | 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), |
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Inclusion Criteria:
Exclusion Criteria:
• Known allergy or contraindication to melatonin.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Banhā | Egypt |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Placebo | Drug | 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, |
|
| 10-30 min from arriving to PACU |
| Postoperative Pain | Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at the same time points as the PAED scale. | first 2 hours postoperative |
| Rescue Analgesia | Total dose of rescue analgesia (e.g., intravenous morphine or fentanyl measured according to the child weight in kg ) required in the PACU. | 24 hours after surgery |
| Adverse Events | 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. | first 24-hour post operative |
| Parent/caregiver satisfaction | 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 | first 24-hour post operative |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |