Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy

Administration of Dexamethasone in PONV Prophylaxis in Children Between 3 and 15 Years of Age Undergoing Adenotomy in General Anaesthesia; Risks and Side Effects of the Treatment

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.

Study Overview

• Status: Completed
• Conditions: Snoring; Otitis; Hearing Loss; Nasal Obstruction; Apnea, Obstructive; Nasopharyngeal Obstruction
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

Detailed Description

Randomization The study subjects were randomized into two arms, using computer-generated sequence of binary code: interventional arm with dexamethasone administration and control group with a placebo - physiological solution. Anaesthesiology nurse, who was not a part of the research team, randomly selected a vial for each enrolled patient, which was later administered to the patient. The number of the ampule corresponded with the patient's number.

Standardized anaesthesiology protocol General anaesthesia was administered in every paediatric patient according to a standardized anaesthesiology protocol. Each subject received premedication with midazolam in the dose of 0.5 mg/kg of body weight, per orally, 45 minutes before the surgical procedure. Inhalation induction of general anaesthesia was initiated with Sevoflurane, the vaporizer was set to 8%, using the carrying mixture of gases O2/air in the 1:1 ratio. After induction of anaesthesia, peripheral venous line was secured, with subsequent administration of an opioid - Sufentanil in the dose of 0.2 uq/kg of body weight, together with the research drug in the dose of 0.15mg/kg of body weight, with the maximum dose of 4 mg administered intravenously. The airways were secured in accordance with standard procedures used at our centre - armed laryngeal mask. In case of any leakages, air leaks, or any other problems with the laryngeal mask, the airways were secured with orotracheal intubation and introduction of tamponade into hypopharynx. General anaesthesia was further maintained using Sevoflurane, towards the values of MAC 1.2-1.5. Fluid therapy was guided by the 4/2/1 ml/kg of body weight /hr. rule - using Ringer's solution. Each subject was given standard analgetization for the early post-operative period: Paracetamol in the dose of 15mg/kg of body weight i.v. in the course of 10 minutes of the surgical procedure. Standard monitoring was provided for every patient: ECG, measurement of blood pressure, saturation, capnometry, inspiration and expiration Sevoflurane concentrations. After the surgery, every patient was woken up from anaesthesia, the laryngeal mask was removed (extubation) with spontaneous ventilation, the patient was further transferred to PACU.

Data collection Anaesthesiology team (anaesthetist + nurse), who was responsible for administration of general anaesthesia according to the standardized protocol, and who was trained to perform the study according to the study protocol, recorded the data concerning Dexamethasone/Placebo administration into a special Case Report Form, containing identification and number of the study drug. The form was transferred together with the patient to PACU, where the occurrence of PONV was monitored and recorded, together with the first value of the BARF score, by a PACU nurse and the child's parent. The form concerning the incidence PONV at inpatient department was provided for the parent who was present at the bedside of the patient at all times, up to the child's discharge from the hospital - the parent noted the number of vomiting episodes and BARF score 8 hours after the surgery (late BARF score); the parent was further instructed to ask the child ever 2 hours about possible sickness. In case of vomiting, the time and number of vomiting episodes were recorded.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; Patients randomised into the Dexamethasone arm will be administered active studied drug during anaesthesia induction.	Drug: Dexamethasone; Dexamethasone will be administered to patients randomised into the active treatment arm, in order to determine the influence upon PONV incidence.
Placebo Comparator: Placebo; Patients randomised into the control Placeboarm will be administered placebo during anaesthesia induction.	Drug: Placebo; Placebo will be administered to patients randomised into the control group arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea incidence	To assess the incidence of nausea in children using BARF score and monitoring of possible difference between the interventional and control groups	24 months

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Michal Frelich, MD, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Nose Diseases; Respiratory Sounds; Sensation Disorders; Respiratory Insufficiency; Hearing Disorders; Airway Obstruction; Sleep Apnea, Obstructive; Snoring; Hearing Loss; Nasal Obstruction; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: FNO-KARIM-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No