2024-02-12
minor
Study Status, Outcome Measures v10
Re-verified, no change to tracked fields
Show 8 earlier versions
2023-11-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start date2023-10-15→2023-11-20
Study sitesdetails revised at 1 of 1 site
2023-09-26
notable
Recruiting→Not Yet Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v7
Trial statusRecruiting→Not Yet Recruiting
Start date2023-08-15→2023-10-15
Secondary endpointsdetails revised at 1 of 4 entries
Study sitesdetails revised at 1 of 1 site
2023-08-16
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start date2023-04-15→2023-08-15
Study sites0→1
Secondary endpoints4 entries, revised
Need for additional anxiolysis or sedation to facilitate repair
2023-03-31
minor
Study Status, Eligibility v5
Eligibility criteria+4 characters
[...] i) Weight >= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or I [...]
2023-03-16
minor
Study Status, Eligibility v4
Start date2023-02-25→2023-04-15
Eligibility criteria+166 characters
Inclusion Criteria:
i) Age 2-12.99 years [ ii) Single laceration requiringfor simplewhich interruptedthe suturestreating alone
Nophysician concomitantbelieves fracturerepair ordoes dislocation
not require IV sedation iii) Repair to beinvolve sutures and performed by the emergencyED physician or theirdesignate 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 only topical anesthetic (LET) and+/or- infiltrat [...] [...]
2023-02-28
minor
Study Status, Outcome Measures, Eligibility v3
Primary completion date2024-09-30→2025-12-31
Completion date2024-12-31→2026-12-31
Start date2022-10-01→2023-02-25
Eligibility criteria+68 characters
Inclusion Criteria:
Age 2-12.99 years (maximum 65 kg to avoid underdosing of intranasal interventions)
Single laceration requiring simple interrupted sutures alon [...] g.
asthma or type II diabetes mellitus)
Exclusion Criteria:
Opioidi) Sedative, sedativeanxiolytic, or anxiolyticalpha-2-adrenergic medicationreceptor administeredagonist < 24 hours prior to procedureinterventions (may compound sedative effect and increase the SAE risk).
History24-hours encompasses the duration of hypersensitivitysedation of most agents.
ii) Hypersensitivity to dexmedetomidine,any midazolam,intervention oriii) nitrous [...] [...]
Secondary endpoints4 entries, revised
Need for additional anxiolysis or sedation
PainLate duringmaladaptive suturingbehaviors
2022-07-06
minor
Study Status, Study Design, Outcome Measures, Eligibility v2
Eligibility criteria-684 characters
Inclusion Criteria:
i) Age 2-12.99 years (maximum 65 kg to avoid potential underdosing of intranasal interventions) ii)
Single laceration requiring simple interrupted sutures alone iii)
No concomitant fracture or dislocation iv)
Repair to be performed by the emergency physician or their designate
Child v)or Anticipatedcaregiver feardesires ofanxiolysis the impendingfor laceration repair using a Children's Fear Scale (CFS) score of > 1.
The CFS will be proxy reported by the caregiver (age < 5 years or developmentally challenged) using the adult version and self-reported in age 5-12 years usi [...] [...]
Secondary endpoints3 to 4 entries
Post-procedurePain lengthduring ofsuturing
Need stayfor physical restraint
2022-06-14
minor
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+696 characters
Inclusion Criteria:
i) Age 12-12.99 years (maximum 65 kg to avoid potential underdosing of intranasal interventions) ii) Single laceration < 5 cm requiring single layer closure with simple interrupted sutures alone
Isolated injury
Managediii) withinNo concomitant fracture or dislocation iv) Repair to be performed by the emergency departmentphysician or their designate v) Anticipated fear of the impending laceration repair using a Children's Fear Scale (CFS) score of > 1.
PredictedThe toCFS resistwill positioningbe proxy reported by the caregiver (age < 5 years or developmentally challenged) us [...] [...]
Secondary endpointsdetails revised at 2 of 3 entries