Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy

NCT03398044 | Completed

• 1 other identifier: FNO-KARIM-5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• PONV incidence

  To determine, whether Dexamethasone administered in single prophylactic dose of 0.15mg/kg of body weight of the child, after general anaesthesia induction, statistically significantly decreases the incidence of PONV in paediatric patients at the age between 3 and 15 undergoing adenotomy

  24 months

Secondary Outcomes (1)

• Nausea incidence

  24 months

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Patients randomised into the Dexamethasone arm will be administered active studied drug during anaesthesia induction.

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Patients randomised into the control Placeboarm will be administered placebo during anaesthesia induction.

Drug: Placebo

Interventions

Dexamethasone DRUG

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

Dexamethasone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age (3-15 years)
• Signed informed consent by legal representatives of the child and patients (depending on the patient's age)
• Patients indicated for surgical procedure: adenotomy

You may not qualify if:

• ASA III and more
• Chronic medication: corticosteroids
• Malignant disease

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Conditions

Nasal Obstruction; Snoring; Sleep Apnea, Obstructive; Hearing Loss; Otitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hearing Disorders; Ear Diseases; Sensation Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michal Frelich, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking was provided by a nurse not participating upon the research.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects were randomised into two arms, one group with active treatment using dexamethasone, and the other arm of subjects receiving placebo.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 12, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)