Distress, Emotional Clinical Trial
— ALICEOfficial title:
Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized 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).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | Inclusion Criteria: i) Age 2-12.99 years [ ii) Single laceration for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designate (trainee) iv) Child or caregiver desires anxiolysis for laceration repair [justification: incorporates family preferences based on their prior experiences or beliefs about child's response] vii) Local anesthesia planned to involve topical anesthetic (LET) +/- infiltrated lidocaine Exclusion Criteria: i) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist < 24 hours prior to interventions (may compound sedative effect and increase the SAE risk). 24-hours encompasses the duration of sedation of most agents. ii) Hypersensitivity to any intervention iii) Occlusion of > 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug absorption) iv) Hemodynamic abnormalities: bradycardia or hypotension < 2 SD of age-related normal value v) IND contraindications: Pre-existing renal insufficiency, uncorrected mineralocorticoid deficiency, pulmonary hypertension, uncorrected cyanotic heart disease, cardiac conduction disorder, pulmonary hypertension, pulmonary edema, vitamin B12 or folate disorder, phenylketonuria, or psychosis vi) Sedation contraindications: Impaired level of consciousness or respiratory instability vii) N2O contraindications: Conditions associated with potential accumulation of gas within body spaces viii) Suspected or confirmed pregnancy (as reported by patient) ix) Inability to vocalize pain due to motor deficits (unable to apply the OSBD-R) x) Caregiver unable to complete study tasks due to insufficient comprehension of either English or French in the absence of a native language interpreter xi) Weight >= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or II (controlled mild to moderate disease) xii) No concomitant fracture or dislocation |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance with intervention administration | Compliance (percent of calculated IN volume given and acceptance of face mask or on-demand mouthpiece (yes/no)) | From drug administration through completion of suturing (40 minutes) | |
Other | Caregiver satisfaction with anxiolysis during laceration repair | Caregiver satisfaction with anxiolysis using a 100 mm visual analog scale. A higher score indicates greater satisfaction. | At discharge (1 minute) | |
Other | 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. | At discharge (1 minute) | |
Other | 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. | During recovery (1 minute) | |
Other | Number of healthcare personnel required during repair | Maximum number of healthcare personnel required at bedside during repair to provide physical restraint or patient care | During procedure (10 minutes) | |
Other | Cost of healthcare personnel required at bedside during repair | Costs of healthcare personnel based on salary per minute required at bedside during repair to provide physical restraint or patient care | During procedure (40 minutes) | |
Other | Cost of interventions | Cost of interventions based on group assignment | During procedure (40 minutes) | |
Other | Total ED length of stay | ED length of stay | During emergency department visit (2 hours) | |
Other | Duration of procedure | Duration of laceration repair | During procedure (40 minutes) | |
Other | Post-intervention length of stay | Length of stay due to anxiolytic | From drug administration to discharge (80 minutes) | |
Other | Nasal irritation | Nasal irritation due IN intervention using the FLACC scale. Measured following IN sprays | During IN intervention administration (2 minutes) | |
Other | Post-procedure length of stay | Post-procedure length of stay | From suturing to discharge (40 minutes) | |
Other | Caregiver state anxiety | Caregiver anxiety related to laceration repair using State Trait Anxiety Inventory Short version - State (STAIS5) | Immediately prior to Phase II (preparation) (1 minute) | |
Primary | 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 | During preparation, suturing, and recovery (20 minutes) | |
Secondary | Adverse effects | Will be based on the Quebec Guidelines and Health Canada reporting standards for sedation in children and include nausea and vomiting | From intervention to 72 hours post-discharge | |
Secondary | Need for additional anxiolysis or sedation to facilitate repair | Need for additional anxiolysis or sedation to facilitate repair | During suturing (10 minutes) | |
Secondary | 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. | During preparation and suturing (10 minutes) | |
Secondary | 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. | From discharge to 72 hours post-discharge |
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