1 Lee-Archer P, et al. BMJ Open 2018;8:e019915. doi:10.1136/bmjopen-2017-019915 Open Access Does dexmedetomidine given as a premedication or intraoperatively reduce post-hospitalisation behaviour change in children? A study protocol for a randomised controlled trial in a tertiary paediatric hospital Paul Lee-Archer, 1,2,3 Craig McBride, 4 Rebecca Paterson, 2 Michael Reade, 3,5 Britta Regli-von Ungern-Sternberg, 6 Deborah Long 1,2 To cite: Lee-Archer P, McBride C, Paterson R, et al. Does dexmedetomidine given as a premedication or intraoperatively reduce post- hospitalisation behaviour change in children? A study protocol for a randomised controlled trial in a tertiary paediatric hospital. BMJ Open 2018;8:e019915. doi:10.1136/ bmjopen-2017-019915 ► Prepublication history for this paper is available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2017- 019915). Received 3 October 2017 Revised 27 December 2017 Accepted 16 February 2018 For numbered affliations see end of article. Correspondence to Dr Paul Lee-Archer; pleearcher@hotmail.com Protocol ABSTRACT Introduction It has been reported that post-hospitalisation behaviour change (PHBC) occurs in over 50% of children undergoing a general anaesthetic and manifests as behaviours such as sleep and eating disorders, defance of authority, nightmares, enuresis and temper tantrums. The effect is usually short-lived (2–4 weeks); 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 previous bad hospital experience, emergence delirium and preschool age. A recent meta- analysis of alpha-2 agonists (including dexmedetomidine) found that they effectively reduce the incidence of emergence delirium but none of the studies looked at longer term outcomes, such as PHBC. Methods and analysis Two-year-old to seven-year-old children requiring general anaesthesia for common day-case procedures will be randomly assigned to one of three groups: a dexmedetomidine pre medication group, an intraoperative dexmedetomidine group and a control group. Baseline anxiety levels of the parent will be recorded and the anxiety of the child during induction of anaesthesia will also be recorded using validated tools. The primary outcome will be negative behaviours after hospitalisation and these will be measured using the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery and the Strengths and Diffculties Questionnaire. These questionnaires will be administered by a blinded researcher at days 3, 14 and 28 post surgery. Ethics and dissemination Ethics approval has been granted by the Children’s Health Queensland human research ethics committee (HREC/15/QRCH/248) and the University of Queensland human research ethics offce (#2016001715). Any amendments to this protocol will be submitted to the ethics committees for approval. Trial registration number ANZCTR:12616000096459; Pre-results. INTRODUCTION  Post-hospitalisation behaviour change (PHBC) after surgery and anaesthesia can be a significant problem for children and parents. The reason children exhibit such negative behaviour changes may be related to the psychological impact of the experience and there may also be a biological component directly related to brain changes from the anaesthesia, the stress response to the procedure and pain associ- ated with the procedure. PHBC manifests as a variety of problematic behaviours, including separation anxiety, sleep disturbances, eating disturbances and aggression. 1 For some chil- dren, these problems persist for months after the operation. 2 Dexmedetomidine adminis- tered in the perioperative period may be effec- tive at reducing the incidence of PHBC, but currently there is no evidence to support its use and a randomised, controlled trial is needed to assess its effectiveness. 3 Incidence The true incidence of PHBC is unknown with wide ranges reported in the literature. Fortier and Kain studied 260 children from the USA undergoing adenotonsillectomy and found 80.4% had PHBC on day 1 post procedure and nearly a third had PHBC on day 14. 1 In an older study, Kain et al found that 54% of Strengths and limitations of this study ► Randomised, controlled, double-blind trial. ► Dexmedetomidine has been studied in relation to emergence delirium, but longer term outcomes are yet to be evaluated. ► Single-centre trial. ► Children with existing behavioural issues excluded, which may limit the generalisability of the study fndings.