Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy
Condition: Nasal Obstruction; Nasopharyngeal Obstruction; Snoring; Apnea, Obstructive; Hearing Loss; Otitis
MeSH terms: Sleep Apnea, Obstructive; Nasal Obstruction; Hearing Loss; Snoring
Study type: Interventional

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.
    

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.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone will be administered to patients randomised into the active treatment arm, in order to determine the influence upon PONV incidence.; Placebo will be administered to patients randomised into the control group arm.
Intervention MeSH terms: Dexamethasone
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)
Primary purpose: Treatment