Trial Outcomes & Findings for Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation (NCT NCT00786916)

Last Updated: 2015-02-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

109 participants

Primary outcome timeframe

during initial 3 minute propofol infusion

Results posted on

2015-02-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	39	36	34
Overall Study COMPLETED	39	36	34
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=39 Participants 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.	Group B n=36 Participants 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.	Group C n=34 Participants 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.	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	109 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	4.7 years STANDARD_DEVIATION 1.61 • n=5 Participants	4.3 years STANDARD_DEVIATION 1.50 • n=7 Participants	5.0 years STANDARD_DEVIATION 1.63 • n=5 Participants	4.67 years STANDARD_DEVIATION 1.58 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	66 Participants n=4 Participants
Region of Enrollment United States	39 participants n=5 Participants	36 participants n=7 Participants	34 participants n=5 Participants	109 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group A n=39 Participants 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.	Group B n=36 Participants 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.	Group C n=34 Participants 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.
Maximal Pain/Discomfort	4.7 units on a scale Standard Deviation 1.61	4.3 units on a scale Standard Deviation 1.50	5.0 units on a scale Standard Deviation 1.63

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael D. Reed, Pharm.D.

Akron Children's Hospital

Phone: 330-543-3193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place