Distraction to Reduce Pain and Distress in the Pediatric Emergency Department
Condition: Children Requiring IV Placement
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Many medical procedures aimed at helping children can cause them pain and distress. If
      children have certain levels of pain or distress, it can have long lasting negative effects.
      The emergency department can be a very stressful place for children and their parents. There
      are also many procedures that children may have in the emergency department that can cause
      pain and distress. These include procedures such as needle pokes, stitches, or setting a
      broken bone. Two common methods of managing a child's pain in the emergency department are
      drugs and distraction. Drugs are not always practical and may come with unwanted side
      effects. Distraction is often used by parents or health professionals to help children deal
      with pain and stress. Distraction can lower the child's pain and distress by moving their
      attention from the painful experience, for example a needle poke, to a more positive feeling
      such as watching a movie, playing a game, or listening to music. This study will test if
      iPads are useful to help lower pain and distress for children (ages 6 to 11 years) who are
      visiting an emergency department and need an intravenous line put in. The results from this
      study could be important for many children receiving medical care, as distraction is safe and
      the use of iPads is enjoyable for many children.
    

Detailed description: 
      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).
    

Intervention name(s): distraction; topical anesthetic cream
Intervention type(s): Other; Other
Intervention description(s): distraction using an iPad with a selection of child-appropriate games; standard care is to use a topical anesthetic cream at the site of planning IV access
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment