PREMIX vs PREMED Intranasal Lidocaine and Midazolam

• Status: Completed
• Trial end date: 2017-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Lidocaine; Midazolam

Criteria

Inclusion Criteria:

1. Between the age of ≥ 6 months or ≤ 7 years old

2. Undergoing a laceration repair

3. Treating physician has determined that patient requires intranasal midazolam to facilitate the laceration repair

Exclusion Criteria:

1. Weight < 5 kg

2. Known allergy to Lidocaine or Midazolam

3. Does not speak English or Spanish

4. Nasal injury precluding IN medication delivery

5. Presence of intranasal obstruction (mucous/blood) not easily cleared with suction or nose blowing

6. Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)

7. Developmental delay, autism, autism spectrum disorder