Status:
TERMINATED
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Association des Médecins d'Urgence du Quebec
Conditions:
Conscious Sedation
Anxiety
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
Though much attention has been given to the practice of parental presence during invasive procedures in children in the ED, few studies have examined the patient's perspective. The only study to have ...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients:
- Patients aged 8 to 18 years old.
- Patients requiring fracture reduction under conscious sedation by emergency department attending physician.
- Patients able to understand basic spoken English or French.
- Inclusion criteria for parents:
- Parents able to understand basic spoken English or French.
- Exclusion criteria for patients:
- Patients with moderate to severe mental retardation
- Patients with altered mental status or intoxication
- Patients with hemodynamic instability or several traumatic injuries (other than fractures) - these patients require several treatments and may not have time to complete our study.
- Exclusion criteria for parents:
- Parents presenting unacceptable behaviors for family presence
- Uncooperative
- Physically aggressive, combative
- Threatening and argumentative
- Unstable emotionally or cannot be calmed
- Intoxicated or altered mental status
- Suspicion of child abuse
- Suspected perpetrator of violent crime
- Parents with moderate to severe mental retardation.
- Pregnant parent
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00809380
Start Date
June 1 2009
End Date
October 1 2011
Last Update
March 19 2013
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5