Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristopher Schroeder, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01342510
First received: April 25, 2011
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the release of bradykinin on injection. This release causes a painful burning sensation in the patient at the site of injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. Currently, pretreatment with lidocaine is commonly administered to prevent propofol injection pain. No studies to date have looked at the combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on injection caused by propofol. In addition, the administration protocols that have been studied thus far do not mirror clinical practice at the University of Wisconsin. The investigators propose studying the use of magnesium and lidocaine in a single syringe for pretreatment of propofol related pain on injection.


Condition Intervention Phase
General Anesthesia
Intravenous Anesthesia
Drug: Magnesium Sulfate
Drug: Lidocaine
Drug: Control
Drug: Lidocaine/Magnesium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of the Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol.

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pain With Injection of Propofol [ Time Frame: Approximately one minute following administration of propofol. ] [ Designated as safety issue: No ]
    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).

  • Number of Patients With Pain Associated With Injection of Propofol. [ Time Frame: < 1 minute. ] [ Designated as safety issue: No ]
    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).


Enrollment: 200
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Lidocaine 50 mg in a 10 cc syringe
Drug: 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.
Drug: 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.
Experimental: Magnesium
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
Drug: 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.
Experimental: Lidocaine/Magnesium
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
Drug: 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.
Drug: 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.
Placebo Comparator: Control
0.9% saline in a 10 cc syringe
Drug: 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.
Drug: 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.

Detailed Description:

This study will involve little if any change from the typical induction of general anesthesia. Considering that lidocaine is routinely used for the induction of anesthesia, and that some anesthesia staff also inject magnesium prior to propofol, there will be little variation in the induction of anesthesia. Patients will be randomly assigned (by microsoft excel program providing a random number 1-4) to one of four groups:

  1. Lidocaine 50 mg in a 10 cc syringe
  2. Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
  3. 0.9% saline in a 10 cc syringe
  4. Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe

Study drugs will be prepared in identical syringes by the Pharmaceutical Research Center (PRC). Study personnel will receive a syringe labeled with the study number as well as a data collection sheet labeled with the study number. A 20 gauge angiocatheter will be inserted into the dorsum of the hand for IV fluids and medication administration. Subjects will be given preoperative 1-2 mg intravenous midazolam for sedation when the subject is en route to the operating room as is typically done at the discretion of the anesthesia provider caring for the patient. After instituting standard monitors and providing preoxygenation, the study drug will be injected. Twenty seconds later, 50 mg of propofol will be injected. Ten seconds after infusion of propofol, the subjects will then be asked a standard question about pain on injection "Are you having pain at your IV site?". Any behavioral signs such as facial grimacing, arm withdrawal, or tears 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 accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears). Study key personnel will do these pain assessments; the behavioral signs and self-reporting of pain will be recorded separate from one another. The induction of anesthesia will then by completed with the appropriate amount of propofol. Formally assessing pain following injection is not something that is standard care but all patients are currently warned prior to injection that they may experience some warmth or burning at the site of their intravenous line.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adults American Society of Anesthesiologists (ASA) physical status 1 and 2 patients selected for general anesthesia.

Exclusion Criteria:

  • age < 18 years
  • allergy to local anesthetics
  • end stage renal disease
  • pregnancy
  • prisoners
  • patients requiring a rapid sequence induction
  • refusal to participate and patients already participating in another study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01342510

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kristopher M Schroeder, MD University of Wisconsin, Madison
  More Information

Publications:

Responsible Party: Kristopher Schroeder, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01342510     History of Changes
Other Study ID Numbers: 2010-0139
Study First Received: April 25, 2011
Results First Received: April 20, 2012
Last Updated: May 21, 2012
Health Authority: United States: University of Wisconsin Institute for Clinical and Translational Research (ICTR) Data Monitoring Committee (DMC)

Keywords provided by University of Wisconsin, Madison:
Intravenous Anesthesia
General Anesthesia

Additional relevant MeSH terms:
Lidocaine
Magnesium Sulfate
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Analgesics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 22, 2014