Distraction to Reduce Pain and Distress: A Randomized Controlled Trial of Children Undergoing Intravenous Placement in the Pediatric Emergency Department

Setting and Study Period: The study will be conducted in the ED of the Stollery Children's Hospital. Patient recruitment is projected to begin in October 2014 and continue to March 2015.

Study Design and Population: The study will be a RCT; the primary outcomes will be the child's self-reported pain and observed behavioural distress. The population is children, ages 6 to 11 years, attending a pediatric ED and requiring IV placement.

Recruitment: Research assistants (RAs) will identify patients attending the ED between the ages of 6 and 11 years. A RA will be on-site from approximately 14:00 to 22:00 daily to identify children who require IV placement; this time corresponds with peak visits requiring IV placements based on data collected in the ED at the Stollery Children's Hospital in team members' previous studies. For those who require IV placement, the RA will further assess child eligibility based on the inclusion / exclusion criteria outlined below. If the child is eligible, the RA will explain the study and invite the parent and child to participate. After obtaining written, informed consent from the parent and assent from the child, the RA will open a prepared randomization envelope and assign the child to one of the two intervention arms. The RA will ask one parent or caregiver for each child to participate and complete all relevant questionnaires.

Baseline Assessment: After informed consent/assent is obtained, the RA will gather information from the parent on baseline demographic variables (e.g., gender, age), presenting signs and symptoms (e.g., chief complaint), and previous history with ED visits and IV placement.

Randomization, Allocation, and Blinding of Study Treatment: Randomization method: A statistician will prepare the randomization sequence using appropriate software and prepare the envelopes. Allocation will be concealed from the RAs, ED staff, child and parent until consent/assent has been obtained. The statistician will maintain the randomization code which will not be broken until data analysis is complete. Allocation: After receiving informed consent/assent, the RA will open the next envelope in a series of consecutively labeled, sealed, opaque envelopes. These will be kept in a secured location in the ED research office. Blinding: Due to the nature of the intervention, it will not be possible to blind the children, parents, or research and ED staff. The children and their parents will be informed that the study is to evaluate different forms of distraction but will not know the study hypothesis for iPads nor what each group is receiving. The data analyst will be blind to treatment assignment through the use of randomization codes that will not be disclosed until analysis is complete.