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Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy

NCT03398044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-06-05

No results posted yet for this study

Summary

Adenotomy, together with tonsillectomy, belongs among the most frequently performed surgical procedures in paediatric patients. These surgical procedures are associated with the second highest incidence of post-operative nausea and vomiting (PONV) (following strabism correction surgery) in paediatric surgery. PONV is associated, apart from the discomfort for the child, with a number of complications: dehydration, metabolic disruption or danger of haemorrhage and aspiration of the gastric content. Adenotomy is a typologically completely different surgical procedure, with a different target structure of the surgery, and the length and invasiveness of the procedure. Thus, it is possible to expect a difference in PONV incidence when compared to tonsillectomy. Adenotomy is a surgical procedure performed namely in children of the pre-school age. This is associated, among others, also with the problem of objectivization of post-operative nausea, which is very difficult to verbalize in small children, being a subjective feeling of body discomfort. It is possible to expect that the overall incidence of PONV will be significantly underestimated.

Conditions

  • Nasal Obstruction
  • Nasopharyngeal Obstruction
  • Snoring
  • Apnea, Obstructive
  • Hearing Loss
  • Otitis

Interventions

DRUG

Dexamethasone

Dexamethasone will be administered to patients randomised into the active treatment arm, in order to determine the influence upon PONV incidence.

DRUG

Placebo

Placebo will be administered to patients randomised into the control group arm.

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Michal Frelich, MD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03398044 on ClinicalTrials.gov