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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Lidocaine | Experimental | Patient to receive 4% lidocaine intranasally prior to midazolam |
|
| Intranasal 0.9% saline | Placebo Comparator | Patient to receive 0.9% Saline intranasally prior to midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Administered intranasally prior to Midazolam administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | immediately after administration of intranasal midazolam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Smith, MD | UAB Department of Pediatrics | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27739142 | Derived | Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intranasal 0.9% Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Inter-Quartile Range | units on a scale | immediately after administration of intranasal midazolam |
|
duration of study (8 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Pruitt | University of Alabama at Birmingham | 2056389587 | cpruitt@peds.uab.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D008874 | Midazolam |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Midazolam | Drug | Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. |
|
|
| 0.9% Saline | Drug | Administered intranasally prior to Midazolam administration. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Intranasal 0.9% Saline |
Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group). |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 37 | 0 | 37 |
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| Aniline Compounds |
| D000588 | Amines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |