- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342510
Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol
The Evaluation of the Combination of Magnesium and Lidocaine for the Pretreatment of Pain That is Caused by the Injection of Propofol.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine
Lidocaine 50 mg in a 10 cc syringe
|
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.
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
|
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
|
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.
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting Pain With Injection of Propofol
Time Frame: 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).
|
Approximately 10 seconds following administration of propofol.
|
Number of Patients With Pain Associated With Injection of Propofol.
Time Frame: < 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).
|
< 1 minute.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristopher M Schroeder, MD, University of Wisconsin, Madison
Publications and helpful links
General Publications
- Johnson RA, Harper NJ, Chadwick S, Vohra A. Pain on injection of propofol. Methods of alleviation. Anaesthesia. 1990 Jun;45(6):439-42. doi: 10.1111/j.1365-2044.1990.tb14328.x.
- Yull DN, Barkshire KF, Dexter T. Pretreatment with ketorolac and venous occlusion to reduce pain on injection of propofol. Anaesthesia. 2000 Mar;55(3):284-7. doi: 10.1046/j.1365-2044.2000.01320.x.
- Huang YW, Buerkle H, Lee TH, Lu CY, Lin CR, Lin SH, Chou AK, Muhammad R, Yang LC. Effect of pretreatment with ketorolac on propofol injection pain. Acta Anaesthesiol Scand. 2002 Sep;46(8):1021-4. doi: 10.1034/j.1399-6576.2002.460816.x.
- Ambesh SP, Dubey PK, Sinha PK. Ondansetron pretreatment to alleviate pain on propofol injection: a randomized, controlled, double-blinded study. Anesth Analg. 1999 Jul;89(1):197-9. doi: 10.1097/00000539-199907000-00035.
- Apiliogullari S, Keles B, Apiliogullari B, Balasar M, Yilmaz H, Duman A. Comparison of diphenhydramine and lidocaine for prevention of pain after injection of propofol: a double-blind, placebo-controlled, randomized study. Eur J Anaesthesiol. 2007 Mar;24(3):235-8. doi: 10.1017/S026502150600202X. Epub 2007 Jan 4.
- Ishiyama T, Kashimoto S, Oguchi T, Furuya A, Fukushima H, Kumazawa T. Clonidine-ephedrine combination reduces pain on injection of propofol and blunts hemodynamic stress responses during the induction sequence. J Clin Anesth. 2006 May;18(3):211-5. doi: 10.1016/j.jclinane.2005.08.005.
- Saadawy I, Ertok E, Boker A. Painless injection of propofol: pretreatment with ketamine vs thiopental, meperidine, and lidocaine. Middle East J Anaesthesiol. 2007 Oct;19(3):631-44. Erratum In: Middle East J Anesthesiol. 2008 Feb;19(4):919.
- Asik I, Yorukoglu D, Gulay I, Tulunay M. Pain on injection of propofol: comparison of metoprolol with lidocaine. Eur J Anaesthesiol. 2003 Jun;20(6):487-9. doi: 10.1017/s0265021503000784.
- Ghai B, Makkar JK, Bala I, Wig J. Effect of parecoxib pretreatment and venous occlusion on propofol injection pain: a prospective, randomized, double-blinded, placebo-controlled study. J Clin Anesth. 2010 Mar;22(2):88-92. doi: 10.1016/j.jclinane.2009.03.011.
- Fujii Y, Itakura M. Comparison of lidocaine, metoclopramide, and flurbiprofen axetil for reducing pain on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, parallel-group, placebo-controlled study. Clin Ther. 2008 Feb;30(2):280-6. doi: 10.1016/j.clinthera.2008.02.018.
- Kwak KH, Ha J, Kim Y, Jeon Y. Efficacy of combination intravenous lidocaine and dexamethasone on propofol injection pain: a randomized, double-blind, prospective study in adult Korean surgical patients. Clin Ther. 2008 Jun;30(6):1113-9. doi: 10.1016/j.clinthera.2008.05.019.
- Agarwal A, Ansari MF, Gupta D, Pandey R, Raza M, Singh PK, Shiopriye, Dhiraj S, Singh U. Pretreatment with thiopental for prevention of pain associated with propofol injection. Anesth Analg. 2004 Mar;98(3):683-6, table of contents. doi: 10.1213/01.ane.0000103266.73568.18.
- Borazan H, Erdem TB, Kececioglu M, Otelcioglu S. Prevention of pain on injection of propofol: a comparison of lidocaine with different doses of paracetamol. Eur J Anaesthesiol. 2010 Mar;27(3):253-7. doi: 10.1097/EJA.0b013e328330eca2.
- Kwak K, Kim J, Park S, Lim D, Kim S, Baek W, Jeon Y. Reduction of pain on injection of propofol: combination of pretreatment of remifentanil and premixture of lidocaine with propofol. Eur J Anaesthesiol. 2007 Sep;24(9):746-50. doi: 10.1017/S026502150600233X. Epub 2007 Jan 30.
- Ayoglu H, Altunkaya H, Ozer Y, Yapakci O, Cukdar G, Ozkocak I. Does dexmedetomidine reduce the injection pain due to propofol and rocuronium? Eur J Anaesthesiol. 2007 Jun;24(6):541-5. doi: 10.1017/S0265021506002250. Epub 2007 Jan 23.
- Memis D, Turan A, Karamanlioglu B, Sut N, Pamukcu Z. The use of magnesium sulfate to prevent pain on injection of propofol. Anesth Analg. 2002 Sep;95(3):606-8, table of contents. doi: 10.1097/00000539-200209000-00020.
- Agarwal A, Dhiraj S, Raza M, Pandey R, Pandey CK, Singh PK, Singh U, Gupta D. Vein pretreatment with magnesium sulfate to prevent pain on injection of propofol is not justified. Can J Anaesth. 2004 Feb;51(2):130-3. doi: 10.1007/BF03018771.
- Gajraj NM, Nathanson MH. Preventing pain during injection of propofol: the optimal dose of lidocaine. J Clin Anesth. 1996 Nov;8(7):575-7. doi: 10.1016/s0952-8180(96)00133-x.
- Sasaki T, Okamura S, Kisara A, Ito M, Yogosawa K, Yagishita Y, Yogosawa T. Effect of lidocaine on pain caused by injection of propofol: comparison of three methods at two injection rates. J Anesth. 1999;13(1):14-6. doi: 10.1007/s005400050015. No abstract available.
- Tramer MR, Glynn CJ. An evaluation of a single dose of magnesium to supplement analgesia after ambulatory surgery: randomized controlled trial. Anesth Analg. 2007 Jun;104(6):1374-9, table of contents. doi: 10.1213/01.ane.0000263416.14948.dc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Lidocaine
- Magnesium Sulfate
Other Study ID Numbers
- H-2010-0139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Anesthesia
-
Universidad de AntioquiaCompletedAnesthesia, General | Anesthesia, IntravenousColombia
-
Children's Hospital of PhiladelphiaErasmus Medical Center; University of Texas Southwestern Medical Center; Children... and other collaboratorsCompletedPediatric Anesthesia | General Anesthesia | ElectroencephalographyUnited States, Australia, Switzerland, China, Netherlands
-
University Hospital, SaarlandCompletedGeneral Anesthesia | Regional Anesthesia | Immune FunctionGermany
-
Tanta UniversityRecruitingSpinal Anesthesia | General Anesthesia | Inguinal Herniorrhaphy | NeonatesEgypt
-
Nordic Pharma SASCompletedSpinal Anesthesia | Outpatient Surgery | Short General AnesthesiaFrance
-
Jagiellonian UniversityRecruitingAnesthesia, General | Analgesics, Opioid | Anesthesia, EndotrachealPoland
-
Antalya Training and Research HospitalCompletedAnesthesia, General | Anesthesia, Spinal | Umbilical CordTurkey
-
Samsung Medical CenterUnknownGeneral Anesthesia | Total Intravenous Anesthesia | Bispectral Index MonitoringKorea, Republic of
-
Armed Forces Hospital, PakistanCompletedGeneral Anesthesia | Epidural AnesthesiaPakistan
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
Clinical Trials on Magnesium Sulfate
-
Aurora Health CareNot yet recruitingAtrial Fibrillation | Tachycardia Atrial | Atrial Flutter With Rapid Ventricular ResponseUnited States
-
University of OklahomaRecruitingAsthma in Children | Asthma AttackUnited States
-
Thomas Jefferson UniversityNot yet recruiting
-
Sohag UniversityRecruitingPost Operative Pain, AcuteEgypt
-
Sohag UniversityCompletedPersistent Pulmonary Hypertension of the Newborn | PPHN | Persistent Fetal CirculationEgypt
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedSevere PreeclampsiaBrazil
-
Queen Sirikit National Institute of Child HealthUnknownAcute Severe AsthmaThailand
-
Assiut UniversityRecruitingIntracranial Pressure Control in Pre-eclampsiaEgypt
-
University of Texas Southwestern Medical CenterCompletedAsthmaUnited States
-
University of MonastirCompletedAtrial FibrillationTunisia