Evaluating Stress Response and Anxiety Score in Paediatric Patients
Condition: Anxiety and Fear; Anesthesia
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To date, there have been no studies done relating serum cortisol levels and intranasal
      dexmedetomidine sedation. However, there was a behavioral study done on pediatric patients
      confirming reduction serum cortisol levels with perioperative dialogue intervention.There
      have been a number of studies done on adult patients indicating that dexmedetomidine was
      indeed capable of reducing level of anxiety with evidence of lower serum cortisol levels.
      Hence, we postulated that intranasal dexmedetomidine administration in pediatric patients
      will lower the serum cortisol levels but we need to evaluate the extent of reduction.
    

Detailed description: 
      Justification of study

      With increase in number of pediatric patients undergoing surgery, efforts need to be placed
      on improving quality of perioperative care and patient comfort Intranasal administration of
      sedative agents will be far more comfortable and create a better environment for patients as
      most children have a fear of needles and may resist intravenous drug administration
      Intranasal administration is also a far simpler and less time-consuming technique with good
      bioavailability of administered drugs Reduction in postoperative analgesia requirement will
      result in early return to daily life activities, early discharge and overall reduced length
      of stay and hospital costs

      Pre and intraoperative

      All perioperative data will be collected by an investigator who is blinded to the patient's
      allocation. Once the caregiver has agreed and consented to participate in this study, upon
      admission (1 day prior to scheduled surgery) a baseline serum cortisol level will be taken
      concurrent with IV line setting and blood investigations. The fasting time for all patients
      will be at least 6 hours prior to surgery with clear fluids being allowed up to 2 hours prior
      to surgery.

      On the day of surgery, the patient and caregiver will be called upon 1 hour prior to
      operating time and baseline hemodynamic parameters will be recorded (blood pressure, heart
      rate and pulse oximetry SpO2). Baseline Modified Yale Preoperative Anxiety Scale (m-YPAS)
      will be used as an assessment tool for measuring level of preoperative anxiety.

      Baseline Modified Yale Preoperative Anxiety scale (m-YPAS) is an established and recognized
      tool for assessment of pediatric anxiety levels preoperatively. It is an observational
      checklist each consisting of four to six distinct behavioral descriptions. Four categories of
      behavior are assessed: activity, vocalizations, emotional expressivity, and state of apparent
      arousal. Partial weights are used to calculate a total score ranging from 23 (low anxiety) to
      100 (high anxiety). Previous research has shown good to excellent inter and intra-observer
      reliability and validity.

      Once the baseline parameters have been recorded, patient will receive the medication
      previously assigned via randomization delivered via mucosal atomizer device (MAD). Drugs will
      be administered by anesthetist or anesthetic medical officer only in safe setting with drugs
      for resuscitation and monitoring equipment available. They will be briefed on the workflow
      and timing of drug administration accordingly. The person responsible for delivering the
      medication will be blinded.

      Hemodynamic parameters will be charted at 10 minutes intervals after the study medications
      have been served. Rescue drugs IV atropine 10 - 20mcg/kg will be given if the patient
      develops bradycardia (less than 2SDs for age) and fluid boluses if blood pressure drops to
      more than 20% of baseline or below 2SD of blood pressure for age.

      2nd Modified Yale Preoperative Anxiety Scale (m-YPAS) will be assessed 10 minutes after
      delivering the study medications. This is followed by sedation score after 30 minutes and
      3rd. m-YPAS if indicated.

      Sedation and behavior score is a simplified scoring system that is based on observational
      charting. It comprises of 2 domains ranging from alert, awake, crying and resisting to asleep
      and not responding to mild prodding or shaking while being calm and cooperative. Higher
      scores indicate a higher level of sedation and are more favorable.

      Once the patient has arrived in the operation theatre, the SpO2 monitoring probe will be
      attached and intravenous induction is carried out with IV Propofol 4 - 5mg/kg. This is
      followed by applying other standard monitoring appliances such as blood pressure cuff and ECG
      electrodes. IV fentanyl 1-2mcg/kg to obtund the laryngeal reflex and paralysis with IV
      esmeron 0.6-1mg/kg. Appropriate size endotracheal tubes (ETT) or laryngeal mask airway (LMA)
      will be inserted accordingly to secure the airway.

      2nd sample of serum cortisol level will be taken within 10 minutes of induction of
      anesthesia. Maintenance of anesthesia with sevoflurane aiming at 1.0 minimum alveolar
      concentration (MAC). Intravenous fluid will be replaced according to (Holiday Segar Formula)
      using either HM solution or sterofundin.

      IV paracetamol 15mg/kg will be given pre-emptively, followed by IV morphine 0.1mg/kg. IV
      Fentanyl boluses 0.5-1mcg/kg will be served if required based on the hemodynamic parameters.

      Postoperative

      Postoperatively patient will be monitored in recovery room for 30 minutes and pain will be
      assessed using Wong Baker Faces pain rating scale/FLACC for smaller children. Rescue
      analgesic IV Fentanyl 0.5-1mcg/kg will be given if required. The total requirement of IV
      Fentanyl and the discharge time will be recorded for reference.

      Wong Baker Faces scale is tool created with children to help them communicate their pain. Now
      the scale is used around the world with people ages 3 and older, facilitating communication
      and improving assessment so pain management can be addressed accordingly. There are 6 faces
      with each face representing a person who has no pain (hurt), or some, or a lot of pain. The
      patient chooses the face that best depicts the pain they are experiencing.

      The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to
      assess pain for children between the ages of 2 months and 7 years or individuals that are
      unable to communicate their pain. It is an observational based scale. The scale is scored in
      a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each
      assigned a score of 0, 1 or 2. Higher scores indicate higher pain.

      Statistical Analysis

      The analyses will be performed using the IBM SPSS Statistics for Windows Version 21.0. The
      data will be manually entered into the software before the cleaning process takes place. The
      cleaning process is crucial to prevent any errors that may skew the results. After that, the
      actual analysis process will be carried out. In this study, descriptive statistics will be
      employed for selected variables. The findings will be presented based on the types of data
      and their distribution. Categorical Data, will be presented as frequencies and percentage.
      Numerical Data will be presented as means and standard deviations if normally distributed,
      and if not, as medians and interquartile ranges.

      Comparison of Numerical Data between two independent groups that are normally distributed
      will be analyzed using the Independent t-test, while Mann-Whitney test will be used if the
      data for two independent groups are not normally distributed.

      Hemodynamic parameters measurement (objective 3) will be analyzed using repeated measures
      ANOVA while Friedman test will be used if the Numerical Data are not normally distributed.
      All probability values are two-sided, and a level of significance of less than 0.05 (p-value
      < 0.05) will be considered as statistically significant
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Evaluating anxiety score in both arms; Evaluating anxiety score in both arms
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of paediatric patients for general anaesthesia one arm: Intranasal dexmedetomidine another arm: Intranasal normal saline (placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Paediatric; Intranasal; General anaesthesia; Dexmedetomidine; Anxiety score; cortisol