PREMIX vs PREMED Intranasal Lidocaine and Midazolam
Condition: Pain
Intervention: Lidocaine; Lidocaine and midazolam (PREMIX); Midazolam
Intervention description: Lidocaine will be administered before administration of midazolam.; Lidocaine will be administered as a mixture with midazolam.; Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
Intervention MeSH terms: Lidocaine; Midazolam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 6 Months
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Intranasal; Pain; Lidocaine; Midazolam; Emergency department

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.
    

Eligibility 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