Anxiolysis for Laceration Repair in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-12
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
About this trial
This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugIntranasal dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)
Midazolam Nasal Spray
DrugIntranasal midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)
Nitrous oxide
Drug50% nitrous oxide in 50% oxygen by face mask
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Intranasal dexmedetomidineExperimental treatment 1 intervention
Group B: Intranasal midazolamExperimental treatment 1 intervention
Group C: Inhaled nitrous oxideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Observational Scale of Behavioral Distress - Revised (OSBD-R)
Score ranges from 0 (no distress) to 23.5 (maximal distress) and will be scored for the time interval encompassing preparation and suturing
Time frame
During preparation, suturing, and recovery (20 minutes)Secondary outcomes
1
Adverse effects
Will be based on the Quebec Guidelines and Health Canada reporting standards for sedation in children and include nausea and vomiting
Time frame
From intervention to 72 hours post-discharge2
Need for additional anxiolysis or sedation to facilitate repair
Need for additional anxiolysis or sedation to facilitate repair
Time frame
During suturing (10 minutes)3
Need for physical restraint
Need for restraint during preparation and suturing based on the Procedural Restraint Intensity in Children (PRIC) scale. The PRIC is scored in discrete integer values from 0=no restraint to 4=extreme forceful restraint. A higher score indicates more restraint is needed.
Time frame
During preparation and suturing (10 minutes)4
Late maladaptive behaviors
Late maladaptive behaviors up to an including 72 hours post discharge using the Post-Hospital Behavior Questionnaire. The scale consists of 27 items concerning sleep, eating, anxiety, etc. where each item is scored from 1-5. The minimum score is 27 and the maximum score is 135 with higher scores indicating greater severity of behaviors.
Time frame
From discharge to 72 hours post-dischargeOther outcomes
1
Compliance with intervention administration
Compliance (percent of calculated IN volume given and acceptance of face mask or on-demand mouthpiece (yes/no))
Time frame
From drug administration through completion of suturing (40 minutes)2
Caregiver satisfaction with anxiolysis during laceration repair
Caregiver satisfaction with anxiolysis using a 100 mm visual analog scale. A higher score indicates greater satisfaction.
Time frame
At discharge (1 minute)3
Child satisfaction with anxiolysis during laceration repair
Child (7-12 years) satisfaction with anxiolysis using a 100 mm visual analog scale. A higher score indicates greater satisfaction.
Time frame
At discharge (1 minute)4
Healthcare provider (physician, nurse, respiratory therapist) satisfaction with anxiolysis during laceration repair
Nurse, physician, parent, and child 7-12 years satisfaction with anxiolysis using a 100 mm visual analog scale. A higher score indicates greater satisfaction.
Time frame
During recovery (1 minute)Sponsors and contacts
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Source ClinicalTrials.gov