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Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398044
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Nasopharyngeal Obstruction Snoring Apnea, Obstructive Hearing Loss Otitis Drug: Dexamethasone Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study subjects were randomised into two arms, one group with active treatment using dexamethasone, and the other arm of subjects receiving placebo.
Masking: Double (Participant, Investigator)
Masking Description: Masking was provided by a nurse not participating upon the research.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 31, 2019


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.




Primary Outcome Measures :
  1. PONV incidence [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Nausea incidence [ Time Frame: 24 months ]
    To assess the incidence of nausea in children using BARF score and monitoring of possible difference between the interventional and control groups



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398044


Locations
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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Michal Frelich, MD University Hospital Ostrava
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03398044    
Other Study ID Numbers: FNO-KARIM-5
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Nasal Obstruction
Hearing Loss
Snoring
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Respiratory Sounds
Signs and Symptoms, Respiratory
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents