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

NCT ID: NCT07116304

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

Propofol is the most popular drug used for induction of anaesthesia. without prophylaxis, 60 to 70% of patients are affected by pain upon injection, with varying degrees of severity. The specific mechanism triggering pain is undetermined, but it is thought to be due to triggering of kallikrein-kinin cascade when it is injected.

Many strategies have been investigated to reduce the severity of this pain, with the most effective being the use of a large vein to deliver the drug, combined with pretreatment using lidocaine with venous occlusion to allow it to anaesthetize the vein locally. This approach has been shown in a large meta-analysis to be the gold standard for reducing pain caused by propofol injection, achieving up to an 80% reduction in incidence. However, this method is not widely used clinically, probably due to the extra time required to anaesthetize the vein and applying a tourniquet. On the other hand, using lidocaine as a pre- treatment or mixed with propofol has been shown to reduce pain on injection.

Multiple other agents have been investigated with the aim of preventing the pain caused by propofol injection, such as opioids and ketamine. Non-steroidal Anti inflammatory Drugs (NSAIDs) have also been studied, with the rationale that reducing prostaglandin production caused by the suggested cascade above. These medications are usually used as part of the multimodal analgesia delivered to the patient to prevent intraoperative and postoperative pain, if given prior to propofol, they may have the added benefit of reducing the pain caused by injecting propofol.

Parecoxib, a selective COX-2 inhibitor in the NSAIDs class, has been investigated recently in trails to prevent pain on injection caused by propofol, where a prospective Randomised controlled trial showed that a dose of 40 mg was effective in reducing the frequency and the severity of the pain, where the incidence of pain was only 26%, compared to 58% in the placebo group. Furthermore non of the patients in this group reported moderate or severe pain. In the same study, a 20 mg Dose was only shown to reduce the severity of pain and not the incidence.

The Investigators propose this study to compare the two interventions as no previous study has investigated them in the same setting.

Objective of the study.

To compare the efficacy of intravenous parecoxib versus lidocaine in reducing pain during propofol injection in adult ASA I-II patients.

Conditions

Preventing Propofol Pain on Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Parecoxib

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.

Group Type: ACTIVE_COMPARATOR

Parecoxib 40mg

Intervention Type: 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.

Lidocaine

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

Group Type: ACTIVE_COMPARATOR

Lidocaine, a local anaesthetic.

Intervention Type: DRUG

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

Interventions

Lidocaine, a local anaesthetic.

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

Intervention Type: DRUG

Parecoxib 40mg

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oman Medical Speciality Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohammed Hamood Alrashdi

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed Alrashdi, Mb BCH BAO

Role: CONTACT

r24005@resident.omsb.org

+96896686858

References

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.

Reference Type: BACKGROUND

PMID: 21455088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9659020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20304348 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21406529 (View on PubMed)

Other Identifiers

MCMSS-MREC 023/2025

Identifier Type: -

Identifier Source: org_study_id