Pain
Conditions
Keywords
Propofol, Lidocaine, Intravenous propofol
Brief summary
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.
Detailed description
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.
Interventions
DRUGLidocaine
Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
DRUGNormal Saline
Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
DRUGPropofol
Intravenous administration of propofol according to standard care to sedate patient.
Sponsors
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* age 2 months to 17 years * patient already scheduled for procedural sedation with propofol * sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists
Exclusion criteria
* patients who are not receiving deep sedation with propofol * patients with allergy or other contraindication to lidocaine administration * patients with central venous catheters as propofol does not burn when given centrally * patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine * patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | 1 minute before propofol induction compared to 1 minute following propofol induction | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Parental Assessment of Child's Pain on a Visual Analog Scale | Immediately following propofol injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 96 |
| 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. | 75 |
| Total | 171 |
Baseline characteristics
| Characteristic | Lidocaine | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 96 Participants | 75 Participants | 171 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 40 Participants | 35 Participants | 75 Participants |
| Sex: Female, Male Male | 56 Participants | 40 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 75 |
| serious Total, serious adverse events | 0 / 96 | 0 / 75 |
Outcome results
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.
Time frame: 1 minute before propofol induction compared to 1 minute following propofol induction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | .82 units on a scale | Standard Deviation 2.357 |
| Normal Saline | Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | 2.43 units on a scale | Standard Deviation 3.268 |
Secondary
Parental Assessment of Child's Pain on a Visual Analog Scale
Time frame: Immediately following propofol injection
Population: This data was not collected.