ABSTRACT
INTRODUCTION: Intravenous (IV) insertions are among the most performed procedures for children seeking medical care; they are often a painful and stressful experience for both children and their caregivers. Paediatric distress and pain that is inadequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for both the family and clinical team. We hypothesise that distraction via an immersive virtual reality (VR) experience may reduce the associated distress for children undergoing IV insertions. METHODS AND ANALYSIS: This two-armed randomised controlled superiority trial will be conducted in a Canadian paediatric emergency department and will aim to enrol 80 children overall. Children will be randomised to receive either departmental standard of care alone or standard of care plus an immersive VR experience. Children 6-17 years of age who are undergoing IV insertion and have topical anaesthetic application will be considered for inclusion. Our primary objective is to compare the reduction of distress between the two study arms. The primary outcome will be the child's observed distress score as measured by the Observational Signs of Behavioral Distress-Revised tool. Secondary outcomes include the child's pain intensity and fear, parental anxiety, satisfaction with the IV procedure, as well as adverse events. Recruitment launched in September 2020 and is expected to end in March 2022. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent will be obtained from parents or guardians, and assent from children. Study data will be submitted for publication irrespective of results. This study is funded through a Women and Children's Health Research Institute Innovation grant. Purchase of the VR equipment was facilitated through a Stollery Children's Hospital Foundation small equipment grant. TRIAL REGISTRATION NUMBER: NCT04291404Cite Now.
Subject(s)
Pain Management , Virtual Reality , Canada , Child , Female , Humans , Pain Management/methods , Pain Measurement , Phlebotomy , Randomized Controlled Trials as TopicABSTRACT
CONTEXT: Opioid-related harms continue to rise for children and youth. Analgesic prescribing decisions are challenging because the risk for future nonmedical opioid use or disorder is unclear. OBJECTIVE: To synthesize research examining the association between short-term therapeutic opioid exposure and future nonmedical opioid use or opioid use disorder and associated risk factors. DATA SOURCES: We searched 11 electronic databases. STUDY SELECTION: Two reviewers screened studies. Studies were included if: they were published in English or French, participants had short-term (≤14 days) or an unknown duration of therapeutic exposure to opioids before 18 years, and reported opioid use disorder or misuse. DATA EXTRACTION: Data were extracted, and methodologic quality was assessed by 2 reviewers. Data were summarized narratively. RESULTS: We included 21 observational studies (49 944 602 participants). One study demonstrated that short-term therapeutic exposure may be associated with opioid abuse; 4 showed an association between medical and nonmedical opioid use without specifying duration of exposure. Other studies reported on prevalence or incidence of nonmedical use after medical exposure to opioids. Risk factors were contradictory and remain unclear. LIMITATIONS: Most studies did not specify duration of exposure and were of low methodologic quality, and participants might not have been opioid naïve. CONCLUSIONS: Some studies suggest an association between lifetime therapeutic opioid use and nonmedical opioid use. Given the lack of clear evidence regarding short-term therapeutic exposure, health care providers should carefully evaluate pain management options and educate patients and caregivers about safe, judicious, and appropriate use of opioids and potential signs of misuse.
