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Completed

NCT Number: NCT05143762

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

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.

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Key information

Conditions

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

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol

Drug

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

Dexamethasone

Drug

patients will receive dexamethasone 0.5mg/kg IV.

normal saline

Drug

patients will receive placebo 10 ml normal saline IV.

Primary outcomes

  1. Total opioid consumption at PACU

    Time frame: two hours postoperatively

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

Secondary outcomes

  1. objective pain score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2021
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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