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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143762
• Other study ID #: 3-10-2021
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• paracetamol
patients will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day)
• Dexamethasone
patients will receive dexamethasone 0.5mg/kg IV.
• normal Saline
patients will receive placebo 10 ml normal saline IV.

Locations

Country	Name	City	State
Egypt	Banha Faculity of Medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption at PACU	total amount of opioid that will be taken by the patients postoperatively.	two hours postoperatively
Secondary	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