Pain
Conditions
Keywords
Children, Midazolam, Lidocaine, Intranasal
Brief summary
The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.
Detailed description
This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P \< 0.05 considered statistically significant.
Interventions
DRUGLidocaine
Administered intranasally prior to Midazolam administration.
DRUGMidazolam
Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
DRUG0.9% Saline
Administered intranasally prior to Midazolam administration.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 6-12 * Previously healthy * Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure
Exclusion criteria
* Moderate to severe asthma or other chronic lung disease * Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed. * Any child presenting with a life-threatening condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort With Intranasal Midazolam Administration | immediately after administration of intranasal midazolam | subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying No Hurt) and a maximum score of 10 (Hurts Worst). Values between include 2 (Hurts Little Bit), 4 (Hurts Little More), 6 (Hurts Even More), and 8 (Hurts Whole Lot.). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Lidocaine Patient to receive 4% lidocaine intranasally prior to midazolam
Lidocaine: Administered intranasally prior to Midazolam administration.
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. | 40 |
| Intranasal 0.9% Saline Patient to receive 0.9% Saline intranasally prior to midazolam
Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
0.9% Saline: Administered intranasally prior to Midazolam administration. | 36 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Intranasal Lidocaine | Intranasal 0.9% Saline | Total |
|---|---|---|---|
| Age, Continuous | 8 years | 9 years | 8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 36 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 19 Participants | 13 Participants | 32 Participants |
| Gender Male | 21 Participants | 23 Participants | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 14 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 22 Participants | 45 Participants |
| Region of Enrollment United States | 40 participants | 36 participants | 76 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 37 |
| serious Total, serious adverse events | 0 / 40 | 0 / 37 |
Outcome results
Primary
Discomfort With Intranasal Midazolam Administration
subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying No Hurt) and a maximum score of 10 (Hurts Worst). Values between include 2 (Hurts Little Bit), 4 (Hurts Little More), 6 (Hurts Even More), and 8 (Hurts Whole Lot.). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain).
Time frame: immediately after administration of intranasal midazolam
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intranasal Lidocaine | Discomfort With Intranasal Midazolam Administration | 3 units on a scale |
| Intranasal 0.9% Saline | Discomfort With Intranasal Midazolam Administration | 8 units on a scale |