Trial Outcomes & Findings for Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol (NCT NCT01342510)
NCT ID: NCT01342510
Last Updated: 2019-05-29
Results Overview
Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Approximately 10 seconds following administration of propofol.
Results posted on
2019-05-29
Participant Flow
Participants were recruited between 6/2011 and 10/2011.
200 participants were consented. The participants were distributed between the groups as follows, 39 participants in the control group, 38 in the lidocaine group, 44 in the magnesium group, and 37 in the magnesium/lidocaine group. Participants did not receive study drug if ASA score or peripheral IV inserted was not a 20 gauge.
Participant milestones
| Measure |
Lidocaine
Lidocaine 50 mg in a 10 cc syringe
|
Magnesium
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
|
Lidocaine/Magnesium
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
|
Control
0.9% saline in a 10 cc syringe
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
38
|
44
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
13
|
11
|
Reasons for withdrawal
| Measure |
Lidocaine
Lidocaine 50 mg in a 10 cc syringe
|
Magnesium
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
|
Lidocaine/Magnesium
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
|
Control
0.9% saline in a 10 cc syringe
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
6
|
13
|
11
|
Baseline Characteristics
Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol
Baseline characteristics by cohort
| Measure |
Lidocaine
n=38 Participants
Lidocaine 50 mg in a 10 cc syringe
|
Magnesium
n=44 Participants
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
|
Lidocaine/Magnesium
n=37 Participants
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
|
Control
n=39 Participants
0.9% saline in a 10 cc syringe
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 18.6 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 16.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
44 participants
n=7 Participants
|
37 participants
n=5 Participants
|
39 participants
n=4 Participants
|
158 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 10 seconds following administration of propofol.Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).
Outcome measures
| Measure |
Lidocaine
n=38 Participants
Lidocaine 50 mg in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Lidocaine: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Magnesium
n=44 Participants
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Lidocaine/Magnesium
n=37 Participants
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Lidocaine/Magnesium: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Control
n=39 Participants
0.9% saline in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Control: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pain With Injection of Propofol
|
29 percentage of patients reporting pain
Interval 17.0 to 45.0
|
57 percentage of patients reporting pain
Interval 42.0 to 70.0
|
41 percentage of patients reporting pain
Interval 26.0 to 56.0
|
46 percentage of patients reporting pain
Interval 32.0 to 61.0
|
PRIMARY outcome
Timeframe: < 1 minute.Ten seconds following injection of propofol, subjects were asked "Are you having pain at your IV site?" Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).
Outcome measures
| Measure |
Lidocaine
n=38 Participants
Lidocaine 50 mg in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Lidocaine: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Magnesium
n=44 Participants
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Lidocaine/Magnesium
n=37 Participants
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Lidocaine/Magnesium: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
Control
n=39 Participants
0.9% saline in a 10 cc syringe
Magnesium Sulfate: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Control: We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
|
|---|---|---|---|---|
|
Number of Patients With Pain Associated With Injection of Propofol.
|
11 participants reporting pain
|
25 participants reporting pain
|
15 participants reporting pain
|
18 participants reporting pain
|
Adverse Events
Lidocaine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Magnesium
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Lidocaine/Magnesium
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine
n=50 participants at risk
Lidocaine 50 mg in a 10 cc syringe
|
Magnesium
n=50 participants at risk
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
|
Lidocaine/Magnesium
n=50 participants at risk
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
|
Control
n=50 participants at risk
0.9% saline in a 10 cc syringe
|
|---|---|---|---|---|
|
General disorders
Pain with injection of propofol
|
22.0%
11/50 • Number of events 11 • Less than one minute following injection in intravenous propofol.
Injection pain was assessed using the following four point scale:0=no pain;1=mild(pain reported only in response to questioning);2=moderate(pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously);and 3=severe(strong vocal response or response accompanied by strong behavioral sign).
|
50.0%
25/50 • Number of events 25 • Less than one minute following injection in intravenous propofol.
Injection pain was assessed using the following four point scale:0=no pain;1=mild(pain reported only in response to questioning);2=moderate(pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously);and 3=severe(strong vocal response or response accompanied by strong behavioral sign).
|
30.0%
15/50 • Number of events 15 • Less than one minute following injection in intravenous propofol.
Injection pain was assessed using the following four point scale:0=no pain;1=mild(pain reported only in response to questioning);2=moderate(pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously);and 3=severe(strong vocal response or response accompanied by strong behavioral sign).
|
36.0%
18/50 • Number of events 18 • Less than one minute following injection in intravenous propofol.
Injection pain was assessed using the following four point scale:0=no pain;1=mild(pain reported only in response to questioning);2=moderate(pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously);and 3=severe(strong vocal response or response accompanied by strong behavioral sign).
|
Additional Information
Kristopher Schroeder, MD
University of Wisconsin School of Medicine and Public Health, Department of Anesthesiology
Phone: 608-263-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place