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Interim analysis indicated treatment was effective and statistically significant
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This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.
The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. |
|
| Normal Saline | Placebo Comparator | Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm. | 1 minute before propofol induction compared to 1 minute following propofol induction |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Assessment of Child's Pain on a Visual Analog Scale | Immediately following propofol injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didima Mon-Sprehe, MD | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
| FG001 | Normal Saline | Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm. | Posted | Mean | Standard Deviation | units on a scale | 1 minute before propofol induction compared to 1 minute following propofol induction |
|
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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 | Lidocaine | Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Doucette | Children's Hospitals and Clinics of Minnesota | 6128137144 | angela.doucette@childrensmn.org |
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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 |
| D000077330 | Saline Solution |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal Saline | Drug | Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation |
|
| Propofol | Drug | Intravenous administration of propofol according to standard care to sedate patient. |
|
|
| Normal Saline |
Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Normal Saline | Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. |
|
|
| Secondary | Parental Assessment of Child's Pain on a Visual Analog Scale | This data was not collected. | Posted | Immediately following propofol injection |
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Normal Saline | Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient. | 0 | 75 | 0 | 75 |
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |