None listed
Conditions
Brief summary
The aim of this project is to assess whether the administration of dexmedetomidine either before or during a child's operation affects the incidence of post-hospitalisation behavioural change (PHBC). It has been reported that PHBC occurs in over 50% of children undergoing a general anaesthetic(1) and manifests as behaviours such as sleep and eating disorders, defiance of authority, nightmares, enuresis and temper tantrums. The effect is usually short-lived, however in 5-10% of children these behaviours can last up to 12 months. The risk factors for developing PHBC include underlying anxiety in the child or parent, a traumatic experience at induction of anaesthesia, emergence delirium and pre-school age. A recent meta-analysis of alpha-2 agonists found that they effectively reduce the incidence of emergence delirium but none of the studies looked at longer term outcomes (2). This study aims to answer the question of whether dexmedetomidine, an alpha-2 agonist, can reduce the incidence of PHBC. Pre-school age children requiring general anaesthesia for common day-case procedures will be randomly assigned to one of three groups: A dexmedetomidne pre-medication group, an intraoperative dexmedetomidine group and a control group. Baseline anxiety levels of the child and parents will be recorded using validated tools and the anxiety of the child during induction of anaesthesia will also be recorded. The primary outcome will be maladaptive behaviours after hospitalisation and these will be measured using the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strengths and Difficulties Questionnaire (SDQ). These questionnaires on children's behaviour will be administered to the parents by a blinded researcher at day 3, 14 and 28 post surgery. 1. Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children:Predictors and outcomes. Arch Pediatr Adolesc Med. 1996; 150:1238-45. 2. Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-adrenergic agonists on postoperative behaviour in children. BJA. 2014; 112(6):982-90.
Interventions
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 1mic
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.
Sponsors
Dr Paul Lee-Archer
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
Age 2 to 7 inclusive Having day case surgical procedure ASA 1 or 2
Exclusion criteria
Emergency surgery Allergy to dexmedetomidine Currently taking antihypertensive medication Existing behavioural problems/Attention Deficit Hyperactivity Disorder (ADHD) - defined as being under the care of a paediatrician for behavioural problems or currently taking medication for behavioural issues/ADHD
Outcome results
None listed