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

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05143762
Collaborator
(none)
90
1
3
5.5
16.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial
Actual Study Start Date :
Oct 15, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group (A)

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

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

Active Comparator: group (B)

will receive dexamethasone 0.5mg/kg IV.

Drug: Dexamethasone
patients will receive dexamethasone 0.5mg/kg IV.

Placebo Comparator: group(C)

will received placebo 10 ml normal saline IV.

Drug: normal Saline
patients will receive placebo 10 ml normal saline IV.

Outcome Measures

Primary Outcome Measures

  1. Total opioid consumption at PACU [two hours postoperatively]

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

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banha Faculity of Medicine Banha Elqalyoubea Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

  • Principal Investigator: fatma ahmed abdelfatah, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Ahmed Abdel Fatah, lecturer, Benha University
ClinicalTrials.gov Identifier:
NCT05143762
Other Study ID Numbers:
  • 3-10-2021
First Posted:
Dec 3, 2021
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Ahmed Abdel Fatah, lecturer, Benha University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022