Pain
Conditions
Keywords
pain, propofol, lidocaine, sedation, pediatric
Brief summary
This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.
Interventions
DRUGnormal saline
A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
DRUGlidocaine
A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
Sponsors
Akron Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* scheduled for painless diagnostic procedures * are ASA I or ASA II
Exclusion criteria
* have an indwelling central venous catheter * have received an analgesic or sedative medication in the previous four hours prior to enrollment * have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations * known hypersensitivity to lidocaine or any component of the formulation * hypersensitivity to another local anesthetic of the amide type * Adam-Stokes syndrome * severe degrees of SA, AV, or intraventricular heart block * allergy to corn-related products * contraindication to propofol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Pain/Discomfort | during initial 3 minute propofol infusion | FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever. |
Countries
United States
Participant flow
Recruitment details
This prospective, randomized, double-blind study was conducted at Akron Children's Hospital. The enrollment period was from 4/8/2008 to 2/9/2010.
Pre-assignment details
Patients between 2 and 7 years of age with ASA 1 or ASA 2 classification and scheduled for painless diagnostic procedures were eligible for exclusion.
Participants by arm
| Arm | Count |
|---|---|
| Group A Saline
normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated. | 39 |
| Group B Lidocaine 0.25 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated. | 36 |
| Group C Lidocaine 0.5 mg/kg
lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated. | 34 |
| Total | 109 |
Baseline characteristics
| Characteristic | Group B | Group C | Group A | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 34 Participants | 39 Participants | 109 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.3 years STANDARD_DEVIATION 1.5 | 5.0 years STANDARD_DEVIATION 1.63 | 4.7 years STANDARD_DEVIATION 1.61 | 4.67 years STANDARD_DEVIATION 1.58 |
| Region of Enrollment United States | 36 participants | 34 participants | 39 participants | 109 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 13 Participants | 43 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 26 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 39 | 0 / 36 | 0 / 34 |
Outcome results
Primary
Maximal Pain/Discomfort
FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever.
Time frame: during initial 3 minute propofol infusion
Population: All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Maximal Pain/Discomfort | 4.7 units on a scale | Standard Deviation 1.61 |
| Group B | Maximal Pain/Discomfort | 4.3 units on a scale | Standard Deviation 1.5 |
| Group C | Maximal Pain/Discomfort | 5.0 units on a scale | Standard Deviation 1.63 |