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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04745260
Other study ID # 2020040016
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source University of Texas at Austin
Contact Brittany J DiFabio, MD
Phone 512-324-0093
Email brittany.difabio@ascension.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intranasal Fentanyl Spray and Intranasal Midazolam Spray
Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg
Intranasal Midazolam Spray
Intranasal Midazolam 0.3mg/kg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

References & Publications (7)

Fein JA, Zempsky WT, Cravero JP; Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine; American Academy of Pediatrics. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2012 Nov;130(5):e1391-405. doi: 10.1542/peds.2012-2536. Epub 2012 Oct 29. — View Citation

Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. — View Citation

Kennedy RM, Luhmann JD. The "ouchless emergency department". Getting closer: advances in decreasing distress during painful procedures in the emergency department. Pediatr Clin North Am. 1999 Dec;46(6):1215-47, vii-viii. Review. — View Citation

Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. — View Citation

Miller JL, Capino AC, Thomas A, Couloures K, Johnson PN. Sedation and Analgesia Using Medications Delivered via the Extravascular Route in Children Undergoing Laceration Repair. J Pediatr Pharmacol Ther. 2018 Mar-Apr;23(2):72-83. doi: 10.5863/1551-6776-23.2.72. Review. — View Citation

Neville DN, Hayes KR, Ivan Y, McDowell ER, Pitetti RD. Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. Acad Emerg Med. 2016 Aug;23(8):910-7. doi: 10.1111/acem.12998. — View Citation

Ryan PM, Kienstra AJ, Cosgrove P, Vezzetti R, Wilkinson M. Safety and effectiveness of intranasal midazolam and fentanyl used in combination in the pediatric emergency department. Am J Emerg Med. 2019 Feb;37(2):237-240. doi: 10.1016/j.ajem.2018.05.036. Epub 2018 May 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Yale Preoperative Anxiety Score (mYPAS) 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. Pre-procedure
Secondary Provider Satisfaction with Procedural Sedation (Visual Analog Score) 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). Immediately after the procedure
Secondary Parent Satisfaction with Anxiolysis (Visual Analog Scale) 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). Immediately after the procedure
Secondary Rate of Treatment Failure Failure of intervention to provide appropriate anxiolysis and need for IV sedation Immediately after the procedure
Secondary Duration of Procedure Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider) Immediately after the procedure
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