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

NCT05143762 | Completed Phase 2

• 1 other identifier: 3-10-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

analgesia; dexamethasone; paracetamol

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption at PACU

  total amount of opioid that will be taken by the patients postoperatively.

  two hours postoperatively

Secondary Outcomes (1)

• objective pain score

  at 0 minute , 30 minutes ,1 hour and 2 hours at PACU

Study Arms (3)

group (A)

ACTIVE COMPARATOR

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

Drug: paracetamol

group (B)

ACTIVE COMPARATOR

will receive dexamethasone 0.5mg/kg IV.

Drug: Dexamethasone

group(C)

PLACEBO COMPARATOR

will received placebo 10 ml normal saline IV.

Drug: normal Saline

Interventions

paracetamol DRUG

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

group (A)

Dexamethasone DRUG

patients will receive dexamethasone 0.5mg/kg IV.

group (B)

normal Saline DRUG

patients will receive placebo 10 ml normal saline IV.

group(C)

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• fatma ahmed abdelfatah, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 3, 2021
• Study Start: October 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

EG (1)