Preemptive Dexamethasone , Paracetamol on Postoperative Period Following Adeno-tonsillectomy in Pediatric .

Study Overview
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Brief Summary
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Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for postponing discharge home are poorly managed pain and PONV.

Detailed Description
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Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for postponing discharge home are poorly managed pain and PONV. As a result, these occurrences should be avoided and managed utilizing a multimodal strategy Because of its low cost and adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen has been recommended for use in children, and its pharmacological safety in this age group has been shown. Dexamethasone is another medication that is used to reduce postoperative pain and PONV in various procedures.

Official Title
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Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial

Conditions
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Analgesia

Intervention / Treatment
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* Drug: paracetamol
* Drug: Dexamethasone
* Drug: normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged between 3 and 16 years. All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique. Exclusion Criteria: psychiatric illness. cardiac disease. renal or hepatic impairment. allergy dexamethasone , paracetamol and opioids.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group (A)<br>will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day). | Drug: paracetamol<br>* patients will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day)<br>|
| Active Comparator: group (B)<br>will receive dexamethasone 0.5mg/kg IV. | Drug: Dexamethasone<br>* patients will receive dexamethasone 0.5mg/kg IV.<br>|
| Placebo Comparator: group(C)<br>will received placebo 10 ml normal saline IV. | Drug: normal Saline<br>* patients will receive placebo 10 ml normal saline IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption at PACU | total amount of opioid that will be taken by the patients postoperatively. | two hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective pain score | pain score will be assessed by 4 points pain scale 0=no pain 1 = mild pain 2= moderate pain 3=severe pain | at 0 minute , 30 minutes ,1 hour and 2 hours at PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, dexamethasone, paracetamol