Clinical trial NCT00809380: Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Official title: Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Conscious Sedation
Anxiety
Keywords: Conscious sedation
Parental presence
Invasive procedure
Children
Anxiety
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Association des Médecins d'Urgence du Quebec
First posted: 2008-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 addressed this issue used a single visual analog scale, which is not a well validated tool to assess children's distress level. Furthermore, no studies have assessed parental presence during fracture reduction; only a few incidental cases were reported in the literature. Finally, most studies evaluating parental presence had methodological limitations because of the absence of a control group.

The investigators seek to assess whether parental presence during fracture reduction under sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and children.


Eligibility criteria: 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

Primary outcomes:
measure: The children's anxiety will be measured using the State-Trait Anxiety Inventory (STAI) score (in children older than 12) or State-Trait Anxiety Inventory for children (STAIC) scores (in children from 8 to 12 years old)
timeFrame: at discharge (2 hours post randomisation)
measure: The parents' anxiety will be measured using the STAI scores.
timeFrame: At discharge (approximately 2 hours post randomisation)
Secondary outcomes:
measure: Procedure time
timeFrame: 1 hours
measure: Doses and types of medications used
timeFrame: 1 hour
measure: Fracture reduction success and failure rates
timeFrame: 1 hour
measure: Attempt of reduction by the residents
timeFrame: 1 hour
measure: STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups
timeFrame: 1 hour
measure: Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale
timeFrame: 1 hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Jocelyn Gravel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Justine's Hospital
name: Nathalie Gaucher, MD
role: PRINCIPAL_INVESTIGATOR
References: