Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair

Anxiety Clinical Trial

Official title:

A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04745260
• Other study ID #: 2020040016
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Facial Laceration
• Facies
• Lacerations

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