Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial (PP)

St. Justine's Hospital

Status: Terminated

Conditions: Conscious Sedation; Anxiety

Treatments: Behavioral: Control; Behavioral: Parental presence

Study type: Interventional

Funder types: Other

Identifiers

NCT00809380

PP

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Parental presence

Experimental group

Description:

Patients in the study group will be accompanied by one of their parents for the whole procedure. Before this, a short explanation of the procedure, the patient's expected behavior during the procedure and what roles parents should play will be given to the parent by the research assistant. Parents will be seated close to the patient's head and will wear radiology proof gowns. If deemed necessary by the attending physician or if their behavior becomes unacceptable, parents can be asked to leave the procedure room at any given time. Parents will be allowed to leave the procedure room if they wish to at any time during the procedure.

Treatment:

Behavioral: Parental presence

Control

Active Comparator group

Description:

One parent will stay with their child until he is in the procedure room and conscious sedation has begun. He will then be asked to leave the room and wait in an adjoining waiting room. The attending physician will invite the parent back in the room once the reduction is complete and the cast is done.

Treatment:

Behavioral: Control