The effect of dexmedetomidine given as a premedication or intraoperatively on post-hospitalisation behavioural change in children: a randomised controlled trial

INTERVENTION: There will be two intervention groups: One group will be randomised to receive dexmedetomidine preoperatively 45 minutes prior to theatre (2 micrograms/kg made up to 1 mL with saline intranasally) and then after induction of anaesthesia they will receive an infusion of saline (1mL/kg) over ten minutes intravenously. The other group will receive a 1mL saline nasal spray 45 minutes prior to theatre and then after induction of anaesthesia they will receive a dexmedetomidine infusion 1mL/kg of 1microgram/mL solution over ten minutes intravenously. The nurse administering the premedication and the anaesthetist administering the infusion will be blinded to group allocation and the solutions will be made to look identical by a clinical trials pharmacist. The timing of administration will be recorded on the medication chart of the patient to monitor adherence. CONDITION: Post Hospitalisation Behaviour Change PRIMARY OUTCOME: Negative behaviours as measured by the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery. This validated instrument is an 11 item parental report measure. It will be administered by a researcher to a parent via telephone interview on day 3, 14 and 28 post procedure. Negative behaviours as measured by the Strength and Difficulties Questionnaire. This is a validated behaviour screening tool for children aged 2 to 16. It has 25 items on 5 scales and will be administered by a researcher to a parent via telephone interview on day 3, 14 and 28 post procedure. SECONDARY OUTCOME: Adverse effects. Common adverse effects of dexmedetomidine include bradycardia and hypotension. These will be assessed and recorded by the recovery nurse by the pulse rate on the pulse oximeter and non‐invasive blood pressure measurement. Analgesic requirements in recovery. The recovery nurse will record any analgesia given on the post‐operative medication chart. Emergence delirium. This will be measured using the Cornell Assessment of Paediatric Delirium (CAP‐D). This scale has been designed to detect hypoactive, hyperactive and mixed delirium in children. General practitioner visits. A researcher will ask parents about any GP visits via telephone interview. Pain at home. This will be assessed by a numeric rating scale (NRS) where a researcher will ask a parent via telephone which whole number from 0 to 10 best reflects the intensity of their child's pain with 0 being no pain and 10 the worst pain imaginable. Pain in recovery. This will be assessed using the Faces, Legs, Activity, Cry, Consolability (FLACC) Scale by the recovery nurse. This validated pain measurement tool is commonly used for children aged 2 months to 7 years. Parental days off work. A researcher will ask the parents about any days off work taken to care for their child via telephone interview. Parental satisfaction. This will be assessed by a researcher asking a parent via telephone interview to rate their overall satisfaction with their child's anaesthetic on a 5 ‐point Likert scale. Time in recovery. The arrival and departure times from recovery are recorded on the hospital theatre computer system. INCLUSION CRITERIA: Age 2 to 7 inclusive Having day case surgical procedure ASA 1 or 2