Assessment of Pain on Propofol Injection.

NCT04673500 | Completed

• 1 other identifier: KingKhalidUH
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Assessment of pain on lidocaine-Propofol admixture injection: Comparing large antecubital vein and small vein dorsum of hand.

• Objective: To evaluate the pain on Propofol - lidocaine admixture injection using different sizes of veins on upper limb.
• Design: Prospective randomized clinical trial Place and duration of study: Department of Anesthesia, King Saud University Riyadh May 1, 2013 - May 31, 2014).
• Patient and methods: Total 160 adult patients were divided in two groups. Age 20-50 years of either gender, American Society of Anesthesiologist (ASA) class 1 and 2, scheduled for elective surgery under general anesthesia were included in the study. Patients with known history of allergy to lidocaine or Propofol, obese patients, anticipated difficult intubation, already on any analgesics and pregnant patients were excluded from the study. Both groups received an admixture of Propofol (1%) - lidocaine (2%) on induction of anesthesia through antecubital vein (Group- 1) or through a vein on dorsum of hand (Group- 2). Pain was assessed as none, mild, moderate or severe. Results: Moderate to severe pain on intravenous injection of Propofol-lidocaine admixture through antecubital vein and small vein on dorsum of hand was 20% vs 71%. Conclusion: There is marked reduction of pain when Propofol - lidocaine admixture was injected through antecubital vein as compared to small vein on dorsum of hand.
• Key words: Propofol, injection, pain

Conditions

Injection Site Irritation

Keywords

Propofol; Injection pain; Veins

Outcome Measures

Primary Outcomes (1)

• Assessment of severity of pain on propofol injection

  A 20 gauge intravenous catheter was inserted either in large antecubital vein or in a small vein on dorsum of hand. An initial 30% of a mixture of propofol lidocaine was given to assess the severity of pain on propofol injection before the patient sleeps. The pain on propofol injection was assessed by numerical rating scale (NRS). 0-10, where 0 is no pain and 10 is worst pain imaginable

  From preoperative to day one postoperative

Secondary Outcomes (1)

• Heart rate

  From base line pre-propofol injection to Intraoperative after full dose of propofol injection.

Study Arms (2)

Propofol-lidocaine through large vein

EXPERIMENTAL

Eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the antecubital fossa and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia.

Drug: Propofol lidocaine through large vein

Propofol-lidocaine through small vein

PLACEBO COMPARATOR

Another eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the dorsum of hand and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia.

Drug: Propofol lidocaine through small vein

Interventions

Propofol lidocaine through large vein DRUG

A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a large antecubital vein to assess pain severity on propofol injection during general anesthesia induction

Also known as: Group I

Propofol-lidocaine through large vein

Propofol lidocaine through small vein DRUG

A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a small vein on the dorsum of hand to assess pain severity on propofol injection during general anesthesia induction

Also known as: Group II

Propofol-lidocaine through small vein

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20 to 50 years of either gender
• ASA ( American Society of Anesthesia) class 1 and 2
• Scheduled for elective surgical procedure under general anesthesia

You may not qualify if:

• Patients with known history of allergy to lidocaine or Propofol
• Obese patients
• Anticipated difficult intubation
• ASA 3 and 4
• Already on any analgesics and pregnant patients

Sponsors & Collaborators

• King Khalid University Hospital: lead

Study Sites (1)

Abdul Sattar Narejo

Riyadh, 7805, Saudi Arabia

Location

Related Publications (15)

• Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.

  PMID: 15579060 BACKGROUND

• Sim JY, Lee SH, Park DY, Jung JA, Ki KH, Lee DH, Noh GJ. Pain on injection with microemulsion propofol. Br J Clin Pharmacol. 2009 Mar;67(3):316-25. doi: 10.1111/j.1365-2125.2008.03358.x. Epub 2008 Dec 10.

  PMID: 19220277 BACKGROUND

• Dubey PK, Kumar A. Pain on injection of lipid-free propofol and propofol emulsion containing medium-chain triglyceride: a comparative study. Anesth Analg. 2005 Oct;101(4):1060-1062. doi: 10.1213/01.ane.0000166951.72702.05.

  PMID: 16192520 BACKGROUND

• Nakane M, Iwama H. A potential mechanism of propofol-induced pain on injection based on studies using nafamostat mesilate. Br J Anaesth. 1999 Sep;83(3):397-404. doi: 10.1093/bja/83.3.397.

  PMID: 10655909 BACKGROUND

• 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.

  PMID: 10389803 BACKGROUND

• Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.

  PMID: 21406529 BACKGROUND

• Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.

  PMID: 21455088 BACKGROUND

• Kim DH, Chae YJ, Chang HS, Kim JA, Joe HB. Intravenous lidocaine pretreatment with venous occlusion for reducing microemulsion propofol induced pain: comparison of three doses of lidocaine. J Int Med Res. 2014 Apr;42(2):368-75. doi: 10.1177/0300060513507391. Epub 2014 Mar 4.

  PMID: 24595146 BACKGROUND

• Bano F, Zafar S, Sabbar S, Aftab S, Haider S, Sultan ST. Intravenous ketamine attenuates injection pain and arterial pressure changes during the induction of anesthesia with propofol: a comparison with lidocaine. J Coll Physicians Surg Pak. 2007 Jul;17(7):390-3.

  PMID: 17686348 BACKGROUND

• Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients. Clin Ther. 2009 Oct;31(10):2107-12. doi: 10.1016/j.clinthera.2009.10.012.

  PMID: 19922881 BACKGROUND

• Alipour M, Tabari M, Alipour M. Paracetamol, ondansetron, granisetron, magnesium sulfate and lidocaine and reduced propofol injection pain. Iran Red Crescent Med J. 2014 Mar;16(3):e16086. doi: 10.5812/ircmj.16086. Epub 2014 Mar 5.

  PMID: 24829787 BACKGROUND

• Rahimzadeh P, Faiz SH, Nikoobakht N, Ghodrati MR. Which one is more efficient on propofol 2% injection pain? Magnesium sulfate or ondansetron: A randomized clinical trial. Adv Biomed Res. 2015 Feb 17;4:56. doi: 10.4103/2277-9175.151593. eCollection 2015.

  PMID: 25802825 BACKGROUND

• Borazan H, Sahin O, Kececioglu A, Uluer MS, Et T, Otelcioglu S. Prevention of propofol injection pain in children: a comparison of pretreatment with tramadol and propofol-lidocaine mixture. Int J Med Sci. 2012;9(6):492-7. doi: 10.7150/ijms.4793. Epub 2012 Aug 15.

  PMID: 22927775 BACKGROUND

• Canbay O, Celebi N, Arun O, Karagoz AH, Saricaoglu F, Ozgen S. Efficacy of intravenous acetaminophen and lidocaine on propofol injection pain. Br J Anaesth. 2008 Jan;100(1):95-8. doi: 10.1093/bja/aem301. Epub 2007 Oct 23.

  PMID: 17959585 BACKGROUND

• Ahmad S, De Oliveira GS Jr, Fitzgerald PC, McCarthy RJ. The effect of intravenous dexamethasone and lidocaine on propofol-induced vascular pain: a randomized double-blinded placebo-controlled trial. Pain Res Treat. 2013;2013:734531. doi: 10.1155/2013/734531. Epub 2013 Jul 15.

  PMID: 23956857 BACKGROUND

Study Officials

• Abdul Sattar Narejo, FCPS, FCAI

  King Khalid University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The whole arm with the intravenous catheter was covered with a green sheet, from where the mixture of propofol-lidocaine was given.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthetist

Model Details: Patients were randomized into two groups, eighty each. In all patients 15 to 30 minutes before shifting to the operation room a 20 gauge intravenous catheter was inserted either in a large antecubital vein (Group-1) or in a vein on dorsum of hand (Group-2). Lactate Ringer infusion was initiated at the rate of 120 ml/h. The arm was covered with green sheet. Patients received admixture of 2% lidocaine (1ml) in 1% propofol (19ml) either through large antecubital vein (Group-1, n = 80) or (Group-2, n = 80) through a vein at dorsum of hand. In both groups initially, thirty percent of the calculated dose of propofol (2mg/kg) was injected through an intravenous catheter. All patients were informed to report the researcher about the intensity of pain they experienced in numbers. Then induction of anesthesia was continued as routine.

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 17, 2020
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)