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Effect of Steroids on Post-tonsillectomy Morbidities

NCT02401529 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-07-15

Study results available
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Summary

This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting

Interventions

DRUG

IV dexamethasone

0.15 mg/kg

DRUG

Oral prednisolone

0.25mg/kg/day for 7 days then tapering for next 7 days

DRUG

Paracetamol

acetaminophen 15 mg/kg/dose every 6 hours

DRUG

IV saline

IV saline

Sponsors & Collaborators

  • King Fahd General Hospital

    lead OTHER_GOV

Principal Investigators

  • Dr.Faris A Bahammam, MD · ORL and Head & Neck Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401529 on ClinicalTrials.gov