Preventing Propofol Pain on InjectionNCT07116304
Comparative Efficacy of IV Parecoxib vs Lidocaine in Reducing Propofol Injection Pain
A study testing Lidocaine, a local anaesthetic. and Parecoxib 40mg in people with Preventing Propofol Pain on Injection, run by Oman Medical Speciality Board.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventing Propofol Pain on Injection
- What is being tested?
- Lidocaine, a local anaesthetic. and Parecoxib 40mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients, ≥18 years
- ASA grading I-II
- Patients undergoing elective surgical procedures across all surgical specialties.
- Can speak Arabic or English
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Efficacy of Intravenous Parecoxib Versus Lidocaine in Reducing Propofol Injection Pain: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Lidocaine, a local anaesthetic., Parecoxib 40mg
- Keywords
- randomised controlled trial, parecoxib, propofol, NSAIDs, pain on injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine, a local anaesthetic.Drug
it will be given as a pretreatment prior to injection of propofol, with a tourniquet applied.
Parecoxib 40mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Lidocaine, a local anaesthetic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pain on injecting propofol after receiving the treatment assigned.
Measured: immediately after injection of 50 mg of propofol.
Secondary outcomes (1)
Severity of pain.
Measured Via Visual analogue scale for pain. The patient will be given 50 mg of propofol and asked if there is any pain, and the severity of the pain. The severity of pain will be graded on the scale between 1 and 10, 10 being the most severe in the scale, and 1 is the minimal pain experienced.
Measured: immediately after injection of propofol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preventing Propofol Pain on InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Hamood Alrashdi, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116304
- Sponsor's protocol ID
- MCMSS-MREC 023/2025
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21455088Tan CH, Onsiong MK. Pain on injection of propofol. Anaesthesia. 1998 May;53(5):468-76. doi: 10.1046/j.1365-2044.1998.00405.x.
PubMed 9659020Ghai 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.
PubMed 20304348Jalota 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.
PubMed 21406529
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Intravenous Parecoxib Versus Lidocaine in Reducing Propofol Injection Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07116304
- Acronym / sponsor ID
- MCMSS-MREC 023/2025
- Conditions
- Preventing Propofol Pain on Injection
- Keywords
- randomised controlled trial, parecoxib, propofol, NSAIDs, pain on injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Active comparator | Drug: Parecoxib 40mgPatients 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. |
| Lidocaine | Active comparator | Drug: Lidocaine, a local anaesthetic.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, ≥18 years
- ASA grading I-II
- Patients undergoing elective surgical procedures across all surgical specialties.
- Can speak Arabic or English
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine, a local anaesthetic.it will be given as a pretreatment prior to injection of propofol, with a tourniquet applied. | Drug | Lidocaine |
| Parecoxib 40mgatients 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. | Drug | Parecoxib |
Primary outcome
incidence of pain on injecting propofol after receiving the treatment assigned.
Time frame: immediately after injection of 50 mg of propofol.
1 secondary outcome
Severity of pain.
Time frame: immediately after injection of propofol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 21455088Walker 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.
- Background: PubMed 9659020Tan CH, Onsiong MK. Pain on injection of propofol. Anaesthesia. 1998 May;53(5):468-76. doi: 10.1046/j.1365-2044.1998.00405.x.
- Background: PubMed 20304348Ghai 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.
- Background: PubMed 21406529Jalota 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, a local anaesthetic. and Parecoxib 40mg in people with Preventing Propofol Pain on Injection, run by Oman Medical Speciality Board.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Alrashdi, Mb BCH BAO (+96896686858, r24005@resident.omsb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pain on injecting propofol after receiving the treatment assigned. (time frame: immediately after injection of 50 mg of propofol.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07116304, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.