Clinical trial NCT04745260: Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Laceration
Anxiety
Keywords: Laceration repair
Facial laceration
Anxiety
Midazolam
Fentanyl
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Score (mYPAS)
timeFrame: Pre-procedure
Secondary outcomes:
measure: Provider Satisfaction with Procedural Sedation (Visual Analog Score)
timeFrame: Immediately after the procedure
measure: Parent Satisfaction with Anxiolysis (Visual Analog Scale)
timeFrame: Immediately after the procedure
measure: Rate of Treatment Failure
timeFrame: Immediately after the procedure
measure: Duration of Procedure
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas at Austin
name: Brittany J DiFabio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s0031-3955(05)70184-x.
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.
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.
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. doi: 10.1097/00000539-199710000-00012.
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. doi: 10.1046/j.1460-9592.2002.00918.x.
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.