Recruitment and data collection

RAs will be on-site from approximately 15:00 to 23:00 daily to identify children who require IVI; this period corresponds with peak visits requiring IVIs based on data collected in the ED at the SCH in team members’ previous studies. The RA will assess child eligibility based on the inclusion/exclusion criteria outlined above. After obtaining written, informed consent from the parent and assent from the child, the RA will access a secure, online randomisation programme which will assign the child to one of the two study arms (see online supplementary appendix 1A for Consent/Assent forms). The RA will identify one parent/caregiver to participate and complete all relevant questionnaires. The RA will gather information from the parent on baseline demographic variables (eg, sex, age), presenting signs and symptoms (eg, chief complaint), and previous history of ED visits and IVI. The RA will then collect baseline heart rate and preprocedure pain scores from the child, and baseline anxiety scores from the parent. If a child is randomised to the robotic distraction arm of the trial, the RA will bring the robot into the room, set it up and explain how to interact with it. Five minutes prior to the start of the procedure, the RA will begin the video recording. The staff nurse will then perform the routine set up for intravenous placement. For the purposes of our study, cleaning of the injection site by the staff nurse will mark the beginning of the procedure. The end of the procedure will be the last point of contact by the staff nurse (ie, taping cannula in place with or without arm board, wrapping arm with gauze and taping the gauze in place). The RA will record maximum heart rate and pain scores from the child and the parent will complete the anxiety scales immediately after the first attempt at intravenous placement. Two minutes after completing the IVI, the staff nurse performing the procedure and the parents will complete the satisfaction questionnaire. Five minutes after the procedure is completed, the RA will stop the video recording. A timer will be used to coordinate all steps; this approach has been used successfully in previous trials by our team.^{31 37} If the first attempt at IVI is unsuccessful, additional attempts will occur after the study protocol is complete and all measures are administered; completion of study steps post-IVI attempt will not delay IVI reattempt by more than 2–3 min. As outcome measures are all captured within the 5–10 min before and after the ED IVI attempt, we anticipate very little missed data, as families will not be leaving the department during this time. As the outer shell of the robot is made of plastic and no internal components can be accessed by common use and handling, it will be sanitised after each use, in keeping with local infection control policy. See figure 2 for study flow schematic.

Flow diagram of study procedures and timing of main outcome assessments. IV, intravenous.

bmjopen-2018-023366supp001.pdf