Comparative Efficacy of IV Parecoxib vs Lidocaine in Reducing Propofol Injection Pain

NCT07116304 | Not Yet Recruiting

• 1 other identifier: MCMSS-MREC 023/2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Propofol is the most popular IV anaesthetic agent used for induction, however one of its known side effects is causing pain on injection, the gold standard method in preventing this pain is using lidocaine prior to injecting propofol. multiple drugs have been investigated to reduce the aforementioned pain, however there has been no study comparing lidocaine to parecoxib, an NSAID.

Conditions

Preventing Propofol Pain on Injection

Keywords

randomised controlled trial; parecoxib; propofol; NSAIDs; pain on injection

Outcome Measures

Primary Outcomes (1)

• incidence of pain on injecting propofol after receiving the treatment assigned.

  immediately after injection of 50 mg of propofol.

Secondary Outcomes (1)

• Severity of pain.

  immediately after injection of propofol.

Study Arms (2)

Parecoxib

ACTIVE COMPARATOR

Patients in this group will receive IV parecoxib 40 mg (the standard full dose for an adult) diluted to a total volume of 5 mL with normal saline. The study drug will be injected into the IV cannula on the dorsum of hand \*\*with a tourniquet applied\*\* on the mid-arm (upper forearm) to occlude venous return. The tourniquet (elastic band) pressure will be just enough to distend veins (similar to when drawing blood) but not cause excessive discomfort. The parecoxib solution will be given over \~5-10 seconds. The tourniquet will remain in place for \*\*2 minutes\*\* after injection, then released. This technique of venous occlusion is borrowed from Bier block and previous studies, aiming to localize the drug in the vein for a short period to maximize local effect. then propofol will be administered.

Drug: Parecoxib 40mg

Lidocaine

ACTIVE COMPARATOR

Patients in this group will receive IV lidocaine at a dose of 0.5 mg/kg (ideal body weight) up to a maximum of 50 mg, diluted to a total of 5 mL. The lidocaine will be given into the hand IV cannula \*\*with a tourniquet\*\* on the forearm, It will likewise dwell for 2 minutes under occlusion before tourniquet release. This tourniquet method for lidocaine is known to significantly improve its efficacy in preventing injection pain

Drug: Lidocaine, a local anaesthetic.

Interventions

Lidocaine, a local anaesthetic. DRUG

it will be given as a pretreatment prior to injection of propofol, with a tourniquet applied.

Lidocaine

Parecoxib 40mg DRUG

atients in this group will receive IV parecoxib 40 mg (the standard full dose for an adult) diluted to a total volume of 5 mL with normal saline.

Parecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, ≥18 years
• ASA grading I-II
• Patients undergoing elective surgical procedures across all surgical specialties.
• Can speak Arabic or English

You may not qualify if:

• Difficulty in communicating.
• Liver Cirrhosis patients
• Renal failure or creatinine clearance (CrCl) ≤ 10umol/L,
• Known Lidocaine, parecoxib and/or propofol allergy.
• patients who are not using propofol for an induction.
• Any known contraindication to propofol, parecoxib or lidocaine. (this will include renal failure or cirrhosis of the liver as noted above)
• Patients refusing to be involved in the study.
• ASA(American society of anaesthesia) grading 3-6.
• Any patient that IV access cannot be established in the dorsum of the hand.
• Pregnant women.
• Patients with chronic pain disorders.
• Patients who received any form of analgesia within the last hour.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Related Publications (4)

• 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

• Tan CH, Onsiong MK. Pain on injection of propofol. Anaesthesia. 1998 May;53(5):468-76. doi: 10.1046/j.1365-2044.1998.00405.x.

  PMID: 9659020 BACKGROUND

• 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.

  PMID: 20304348 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

MeSH Terms

Interventions

Lidocaine; parecoxib

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mohammed Alrashdi, Mb BCH BAO

CONTACT

+96896686858; r24005@resident.omsb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share