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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05143762
Enrollment
90
Registered
2021-12-03
Start date
2021-10-15
Completion date
2022-04-01
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

analgesia, dexamethasone, paracetamol

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.

Interventions

DRUGparacetamol

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

DRUGDexamethasone

patients will receive dexamethasone 0.5mg/kg IV.

DRUGnormal Saline

patients will receive placebo 10 ml normal saline IV.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 16 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Total opioid consumption at PACUtwo hours postoperativelytotal amount of opioid that will be taken by the patients postoperatively.

Secondary

MeasureTime frameDescription
objective pain scoreat 0 minute , 30 minutes ,1 hour and 2 hours at PACUpain score will be assessed by 4 points pain scale 0=no pain 1 = mild pain 2= moderate pain 3=severe pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026