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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:April 2011
End Date:April 2012

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

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.

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.

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
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