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

Phase 2

Completed

• Conditions: Analgesia
• Interventions: Drug: paracetamol; Drug: normal Saline; Drug: Dexamethasone

• Registration Number: NCT05143762
• Lead Sponsor: Benha University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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Exclusion Criteria

• psychiatric illness.
• cardiac disease.
• renal or hepatic impairment.
• allergy dexamethasone , paracetamol and opioids.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (A)	paracetamol	will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day).
group(C)	normal Saline	will received placebo 10 ml normal saline IV.
group (B)	Dexamethasone	will receive dexamethasone 0.5mg/kg IV.

Primary Outcome Measures

Name	Time	Method
Total opioid consumption at PACU	two hours postoperatively	total amount of opioid that will be taken by the patients postoperatively.

Secondary Outcome Measures

Name	Time	Method
objective pain score	at 0 minute , 30 minutes ,1 hour and 2 hours at PACU	pain score will be assessed by 4 points pain scale 0=no pain 1 = mild pain 2= moderate pain 3=severe pain

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banha, Elqalyoubea, Egypt