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

Benha University

Status and phase: Completed; Phase 2

Conditions: Analgesia

Treatments: Drug: Dexamethasone; Drug: paracetamol; Drug: normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05143762

3-10-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

group (A)

Active Comparator group

Description:

will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day).

Treatment:

Drug: paracetamol

group (B)

Active Comparator group

Description:

will receive dexamethasone 0.5mg/kg IV.

Treatment:

Drug: Dexamethasone

group(C)

Placebo Comparator group

Description:

will received placebo 10 ml normal saline IV.

Treatment:

Drug: normal Saline