Lignocaine versus opioids in myocardial infarction (AVOID-2)

Lignocaine versus opioids as analgesia in myocardial infarction - assessment of efficacy and safety

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001521112

Acronym

AVOID-2

Enrollment

300

Registered

2019-11-04

Start date

2020-01-01

Completion date

2021-12-01

Last updated

2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is some concern that medications called opioids, which are used to treat pain, may delay the onset of blood thinning medications that are vital to improving patient outcomes after a heart attack. This study seeks to enrol patients suspected of having a heart attack to compare the safety and effectiveness of a different type of painkiller called lignocaine (which does not appear to interact with blood thinners) to fentanyl which is the current standard of care opioid used. We hypothesise that use of lignocaine will be safe and effective for pain related to a heart attack. Ambulance Victoria paramedics will randomise patients with suspected heart attacks to receive either intravenous lignocaine or intravenous fentanyl and assess its effectiveness as pain relief and also side effects (safety) in each group. We will also assess size of the heart attack based on blood testing as well as clinical outcomes during follow-up.

Interventions

Patients will be randomised to receive lignocaine as analgesia in STEMI at a dose of 50mg intravenously over 2 minutes if weight is less than 70kg or 100mg intravenously over 2 minutes if weight is equal to or over 70kg. An additional 50-100mg may be administered every 15 minutes (maximum 300mg total dose) thereafter if patients have a pain score of greater than or equal to 5 (NRS) .

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Adult age greater than or equal to 18 years or older • 12-lead ECG consistent with STEMI • Chest pain greater than or equal to 5/10 • Transfer to a primary PCI centre in metropolitan Melbourne

Exclusion criteria

• No IV inserted • Opioids administered prior to randomisation • Known hypersensitivity to opioids or lignocaine • HR < 50 bpm • Out of hospital cardiac arrest (chest compressions or defibrillation) or cardiogenic shock (SBP<90mmHg) • Regular opioid use • Past history of epilepsy • Stage IV or V chronic kidney disease • Known cirrhotic liver disease • Patient dependent on others for activities of daily living

Outcome results