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

NCT ID: NCT05143762

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-04-01

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group (A)

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

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

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

group (B)

will receive dexamethasone 0.5mg/kg IV.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

patients will receive dexamethasone 0.5mg/kg IV.

group(C)

will received placebo 10 ml normal saline IV.

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

patients will receive placebo 10 ml normal saline IV.

Interventions

paracetamol

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

Intervention Type: DRUG

Dexamethasone

patients will receive dexamethasone 0.5mg/kg IV.

Intervention Type: DRUG

normal Saline

patients will receive placebo 10 ml normal saline IV.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Abdel Fatah

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fatma ahmed abdelfatah, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

Banha Faculity of Medicine

Banhā, Elqalyoubea, Egypt

Countries

Egypt

Other Identifiers

3-10-2021

Identifier Type: -

Identifier Source: org_study_id