Pain Clinical Trial
— ERPainOfficial title:
Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?
Verified date | September 2013 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).
Status | Completed |
Enrollment | 131 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 3 Years to 5 Years |
Eligibility |
Inclusion Criteria: Participants will be eligible for this study if they: - Are between 3-5 years of age - Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation. - Are able to read and speak English - Provide written parental authorization Exclusion Criteria: Participants will be excluded for this study if they: - Are in critical condition as determined by ED staff - Are in significant pain for other reasons other than the venipuncture - Have severe cognitive delay - Require sedation for the venipuncture as determined by the ED staff |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
IWK Health Centre | Mayday Fund |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CAMPIS coding of visual pain response video-recorded during the procedure | continuous | No | |
Secondary | Parental reports of: Child pain ratings (Faces Pain Scale Revised) | post-procedure | No | |
Secondary | Child anxiety ratings | post procedure | No | |
Secondary | CHEOPS analysis | post procedure | No |
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