PREMIX vs PREMED Intranasal Lidocaine and Midazolam
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any - 7 |
| Updated: | 4/17/2018 |
| Start Date: | April 3, 2017 |
| End Date: | October 10, 2017 |
Comparison of Two Methods Using Intranasal Lidocaine to Alleviate Discomfort Associated With Administration of Intranasal Midazolam in Children.
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.
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.
We will enroll 50 children to determine whether the PREMED method is non-inferior to the
PREMIX method. We based our sample size on the outcome of pain and distress associated with
the administration of IN midazolam, which will be measured using our primary outcome measure
of the Observational Scale of Behavioral Distress-Revised (OSBD-R). The OSBD-R is an
observational measure of distress that has been well validated in the pediatric population
for evaluating painful and distressing procedures, and has been used in children as young as
1 year of age [1,2]. The sample size of 50 patients was determined based on a prestated
margin of non-inferiority (delta) of 1.8 (SD 2.25). This value was based on the minimum
clinically significant differences used in prior studies of painful procedures in children in
the emergency department [3,4,5]. To determine noninferiority using a delta of 1.80 (SD
2.25), with a 1-tailed alpha of 0.025 and power of 80%, we would require 25 patients in each
arm, for a total of 50 patients. OSBD-R scores will be determined independently by two
blinded trained assessors who will review the videotapes of the study procedures. Interrater
reliability of the OSBD-R between the two assessors will evaluated by determining the
intraclass correlation coefficient. The period of administration of the midazolam alone in
the PREMED group and the period of administration of the midazolam/lidocaine mixture in the
PREMIX group are the two phases which will be compared to each other to determine our primary
outcome.
Secondary outcome measures of pain and distress associated with IN midazolam administration
will include the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS); the
Faces-LegsActivity-Crying-Consolability (FLACC) scale; and cry duration. These are all
continuous measures that will be analyzed using the independent samples t-test.We will also
evaluate parental and provider satisfaction across various domains using a 5-point Likert
scale (see attached document for questions to be asked). Responses will be dichotomized into
"agree" (i.e. if respondent answers "agree" or "strongly agree") or "disagree" (i.e. if
respondent responds "undecided", "disagree", or "strongly disagree") and analyzed using the
chi square test.
PREMIX method. We based our sample size on the outcome of pain and distress associated with
the administration of IN midazolam, which will be measured using our primary outcome measure
of the Observational Scale of Behavioral Distress-Revised (OSBD-R). The OSBD-R is an
observational measure of distress that has been well validated in the pediatric population
for evaluating painful and distressing procedures, and has been used in children as young as
1 year of age [1,2]. The sample size of 50 patients was determined based on a prestated
margin of non-inferiority (delta) of 1.8 (SD 2.25). This value was based on the minimum
clinically significant differences used in prior studies of painful procedures in children in
the emergency department [3,4,5]. To determine noninferiority using a delta of 1.80 (SD
2.25), with a 1-tailed alpha of 0.025 and power of 80%, we would require 25 patients in each
arm, for a total of 50 patients. OSBD-R scores will be determined independently by two
blinded trained assessors who will review the videotapes of the study procedures. Interrater
reliability of the OSBD-R between the two assessors will evaluated by determining the
intraclass correlation coefficient. The period of administration of the midazolam alone in
the PREMED group and the period of administration of the midazolam/lidocaine mixture in the
PREMIX group are the two phases which will be compared to each other to determine our primary
outcome.
Secondary outcome measures of pain and distress associated with IN midazolam administration
will include the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS); the
Faces-LegsActivity-Crying-Consolability (FLACC) scale; and cry duration. These are all
continuous measures that will be analyzed using the independent samples t-test.We will also
evaluate parental and provider satisfaction across various domains using a 5-point Likert
scale (see attached document for questions to be asked). Responses will be dichotomized into
"agree" (i.e. if respondent answers "agree" or "strongly agree") or "disagree" (i.e. if
respondent responds "undecided", "disagree", or "strongly disagree") and analyzed using the
chi square test.
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
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Daniel S Tsze, MD, MPH
Phone: 212-305-9825
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