Distraction to Reduce Pain and Distress 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.

Study Intervention and Comparison: The intervention will be the use of an iPad that will include a selection of child-appropriate games. We will select popular, age-appropriate items to include on the iPad, chosen based on the most current online consumer ratings. Children and parents will be able to select their choice of distraction and can change their selection as desired during the course of the procedure. These choices will be recorded for study purposes. The control group will receive standard care, which generally includes the use of topical anesthetic cream. This comparison is based on the pragmatic preferences of physicians at the Stollery Children's Hospital as well as precedent in the literature. Overall, it is felt that any new intervention (e.g., iPad) should be compared to what is currently in practice (i.e., standard care), as no single distraction therapy is consistently and routinely employed in EDs at this time.

Study Outcomes: The primary outcomes are patient pain and distress. Self-reported pain will be measured using the Faces Pain Scale-Revised (FPS-R). This measurement will be made immediately following the initial attempt at IV placement. The FPS-R is the currently recommended pain scale for our participant group with strong evidence of validity and reliability for our age range. Distress will be measured using the Observed Scale of Behavioral Distress-Revised (OSBD-R); a tool designed to assess a child's behavioural response to painful medical procedures. The scale scores are reliable and valid for our target population. Two research students will be trained in the use of the tool and will independently observe a videotape of each child and record the frequency of operationally-defined distress-related behaviours during continuous 15-second intervals before, during, and after the procedure. This protocol for use of the OSBD-R is standard; it has been used in other trials evaluating distraction, including a trial by one of the PIs (LH) evaluating music. The secondary outcomes are (a) observed pain which will be measured by the research students using a standard 100 mm visual analogue scale; (b) parent and provider satisfaction (measured using Likert scales); (c) ease of performing the procedure assessed by the provider; time to complete the procedure; (d) success of the procedure; and (e) parent state anxiety measured with a validated instrument, the State Trait Anxiety Inventory (STAI-S, Form Y).