Anxiety, Facial Laceration
Conditions
Keywords
Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl
Brief summary
The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.
Detailed description
This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.
Interventions
DRUGIntranasal Fentanyl Spray and Intranasal Midazolam Spray
Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg
DRUGIntranasal Midazolam Spray
Intranasal Midazolam 0.3mg/kg
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A non-blinded researcher (physician) will determine the group to which the patient is assigned and order the medication(s) according to the assigned group. A separate blinded researcher (physician) will then perform the laceration repair, mYPAS, and post-procedure evaluations. The non-blinded researcher, nurse, parent, and patient will be advised not to disclose which medication(s) were administered to ensure blinding of the provider performing the laceration repair and assessment.
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Facial laceration requiring repair with sutures * English or Spanish-speaking parent/guardian
Exclusion criteria
* Lacerations requiring IV sedation or subspecialist involvement * Patient has other injuries requiring medical attention * Patient has vital sign instability, per physician discretion * Patient has autism spectrum disorder * Patient has allergies to either medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Yale Preoperative Anxiety Score (mYPAS) | Pre-procedure | mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Satisfaction with Procedural Sedation (Visual Analog Score) | Immediately after the procedure | VAS (visual analog score) completed by blinded researcher (provider) to rate satisfaction with level of sedation and ease of procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied). |
| Parent Satisfaction with Anxiolysis (Visual Analog Scale) | Immediately after the procedure | VAS (visual analog score) completed by parent to rate satisfaction with level of anxiolysis for procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied). |
| Rate of Treatment Failure | Immediately after the procedure | Failure of intervention to provide appropriate anxiolysis and need for IV sedation |
| Duration of Procedure | Immediately after the procedure | Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider) |
Contacts
Primary ContactBrittany J DiFabio, MD
Backup ContactMatthew Wilkinson, MD
Outcome results
None listed