PREMIX vs PREMED Intranasal Lidocaine and Midazolam

NCT03054844 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAQ6408
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and distressing procedures, such as laceration repairs. Intranasal midazolam is both effective and safe in children. However, due to the acidic nature of midazolam, there is a burning sensation that is associated with the intranasal administration of midazolam. The use of IN lidocaine has been shown to decrease the pain associated with the administration of IN midazolam and other acidic solutions. The IN lidocaine can be given as a premedication (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then followed by the administration of the IN midazolam. Lidocaine can also be given concurrently with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined mixture administered. Both methods have been shown to be effective in decreasing the pain associated with the intranasal administration of acidic solutions, such as midazolam, although the PREMIX method could have the advantage of requiring less number of sprays, and be tolerated better by children. Although both methods have been shown to work, it is not known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and distress associated with administering IN midazolam. Therefore, the investigators aim to determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to decrease the pain and distress associated with the administration of IN midazolam in children.

Conditions

Pain

Keywords

Intranasal; Pain; Lidocaine; Midazolam; Emergency department

Outcome Measures

Primary Outcomes (1)

• Procedural Distress, OSBD-R

  The Observational Scale of Behavioral Distress-Revised (OSBD-R) is an observational measure of pain and distress shown to have strong validity in children. The scale is an 8-factor, weighted observational scale used to measure distress associated with medical procedures, which has been validated in children and adults aged 1 to 20 years. The total Observational Scale of Behavioral Distress-Revised score is the sum of the scale scores for each phase, with each phase assigned a score from 0 to 23.5 units on a scale (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a predetermined number of 15-second intervals during each phase. There were four phases so the range of scores for the total OSBD-R was 0 to 94 units on a scale, with a higher score indicated a greater degree of distress.

  10 minutes

Secondary Outcomes (5)

• Procedural Pain

  10 minutes

• Procedural Distress, FLACC

  10 minutes

• Procedural Distress, Cry Duration

  10 minutes

• Parental Satisfaction

  1 minute

• Provider Satisfaction

  1 minute

Study Arms (2)

PREMED

EXPERIMENTAL

Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.

Drug: Lidocaine; Drug: Midazolam

PREMIX

EXPERIMENTAL

Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).

Drug: Lidocaine and midazolam (PREMIX)

Interventions

Lidocaine DRUG

Lidocaine will be administered before administration of midazolam.

Also known as: PREMED

PREMED

Lidocaine and midazolam (PREMIX) DRUG

Lidocaine will be administered as a mixture with midazolam.

Also known as: PREMIX

PREMIX

Midazolam DRUG

Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.

PREMED

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the age of ≥ 6 months or ≤ 7 years old
• Undergoing a laceration repair
• Treating physician has determined that patient requires intranasal midazolam to facilitate the laceration repair

You may not qualify if:

• Weight \< 5 kg
• Known allergy to Lidocaine or Midazolam
• Does not speak English or Spanish
• Nasal injury precluding IN medication delivery
• Presence of intranasal obstruction (mucous/blood) not easily cleared with suction or nose blowing
• Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)
• Developmental delay, autism, autism spectrum disorder

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Related Publications (5)

• Tsze DS, Steele DW, Machan JT, Akhlaghi F, Linakis JG. Intranasal ketamine for procedural sedation in pediatric laceration repair: a preliminary report. Pediatr Emerg Care. 2012 Aug;28(8):767-70. doi: 10.1097/PEC.0b013e3182624935.

  PMID: 22858745 BACKGROUND

• Tsze DS, Ieni M, Fenster DB, Babineau J, Kriger J, Levin B, Dayan PS. Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial. Ann Emerg Med. 2017 May;69(5):600-609. doi: 10.1016/j.annemergmed.2016.08.450. Epub 2016 Nov 4.

  PMID: 27823876 BACKGROUND

• Fenster DB, Dayan PS, Babineau J, Aponte-Patel L, Tsze DS. Randomized Trial of Intranasal Fentanyl Versus Intravenous Morphine for Abscess Incision and Drainage. Pediatr Emerg Care. 2018 Sep;34(9):607-612. doi: 10.1097/PEC.0000000000000810.

  PMID: 27387971 BACKGROUND

• Godambe SA, Elliot V, Matheny D, Pershad J. Comparison of propofol/fentanyl versus ketamine/midazolam for brief orthopedic procedural sedation in a pediatric emergency department. Pediatrics. 2003 Jul;112(1 Pt 1):116-23. doi: 10.1542/peds.112.1.116.

  PMID: 12837876 BACKGROUND

• Lee-Jayaram JJ, Green A, Siembieda J, Gracely EJ, Mull CC, Quintana E, Adirim T. Ketamine/midazolam versus etomidate/fentanyl: procedural sedation for pediatric orthopedic reductions. Pediatr Emerg Care. 2010 Jun;26(6):408-12. doi: 10.1097/PEC.0b013e3181e057cd.

  PMID: 20502386 BACKGROUND

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Lidocaine; Midazolam; Premix 730-4

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Daniel Tsze
• Organization: Columbia University

dst2141@columbia.edu

212-305-9825

Study Officials

• Daniel S Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics at CUMC

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 16, 2017
• Study Start: April 3, 2017
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)