Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001072404p
Ethics application status
Submitted, not yet approved
Date submitted
9/09/2025
Date registered
1/10/2025
Date last updated
6/10/2025
Date data sharing statement initially provided
1/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous Lignocaine for Acute Migraine
Scientific title
IV Lignocaine for Acute Migraine: A Pilot Study Evaluating Efficacy in the Emergency Department
Secondary ID [1] 315341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 338823 0
Condition category
Condition code
Emergency medicine 335118 335118 0 0
Other emergency care
Neurological 335235 335235 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medications will be administered by the nurse involved in the patients care. Total dose, timing and any side effects will be documented in the case report form.
Intravenous lignocaine 1.5mg/kg (maximum 150mg) over 3-5 minutes followed by 10mg iv dexamethasone then lignocaine 1mg/kg in 1L 0.9% saline over 60 minutes.
Intervention code [1] 331948 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342755 0
Mean change in pain score
Timepoint [1] 342755 0
120 minutes post-completion of lignocaine infusion (intervention)
Secondary outcome [1] 452010 0
Mean change in pain score
Timepoint [1] 452010 0
30 and 60 minutes post-completion of lignocaine infusion (intervention)
Secondary outcome [2] 452011 0
Requirement for rescue medication
Timepoint [2] 452011 0
Within the four hours following the lignocaine infusion
Secondary outcome [3] 452012 0
Known side effects of lignocaine: tinnitus & perioral numbness
Timepoint [3] 452012 0
From intervention until discharge
Secondary outcome [4] 452013 0
Emergency Department length of stay (minutes)
Timepoint [4] 452013 0
At discharge from the emergency department or on admission to hospital
Secondary outcome [5] 452348 0
Allergy
Timepoint [5] 452348 0
From intervention until discharge
Secondary outcome [6] 452349 0
Incidence of hypotension
Timepoint [6] 452349 0
From intervention until discharge
Secondary outcome [7] 452350 0
Incidence of cardiac arrythmia
Timepoint [7] 452350 0
From intervention until discharge
Secondary outcome [8] 452351 0
Nausea
Timepoint [8] 452351 0
From intervention until discharge
Secondary outcome [9] 452352 0
Sedation
Timepoint [9] 452352 0
From intervention until discharge

Eligibility
Key inclusion criteria
Adults aged greater then or equal to 18 years
Presenting to the emergency department with a migraine not responding to the patient’s usual analgesic choice
Patients previously enrolled are eligible for repeat inclusion if they present with a separate episode of migraine unrelated to the previously treated migraine
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected secondary headache
Thunderclap headache
Presence of fever
Neurological deficits
Altered mental status
First presentation of headache in a patient aged >50 years
Symptoms suggestive of temporal arteritis
Signs of meningeal irritation
Post-traumatic headache
Pregnancy
Inability or unwillingness to provide informed consent
Known allergy to lignocaine

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/02/2026
Actual
Date of last participant enrolment
Anticipated
8/02/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28456 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 44685 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 319920 0
Government body
Name [1] 319920 0
Wide Bay Hospital and Health Service
Country [1] 319920 0
Australia
Primary sponsor type
Government body
Name
Wide Bay Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 322456 0
None
Name [1] 322456 0
Address [1] 322456 0
Country [1] 322456 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318467 0
Coronial and Public Health Sciences Human Ethics Committee
Ethics committee address [1] 318467 0
Ethics committee country [1] 318467 0
Australia
Date submitted for ethics approval [1] 318467 0
02/10/2025
Approval date [1] 318467 0
Ethics approval number [1] 318467 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144286 0
Dr Thomas Papior
Address 144286 0
Bundaberg Hospital, PO Box 34, Bundaberg, QLD 4670
Country 144286 0
Australia
Phone 144286 0
+61 0741502220
Fax 144286 0
Email 144286 0
[email protected]
Contact person for public queries
Name 144287 0
Thomas Papior
Address 144287 0
Bundaberg Hospital, PO Box 34, Bundaberg, QLD 4670
Country 144287 0
Australia
Phone 144287 0
+61 0741502222
Fax 144287 0
Email 144287 0
[email protected]
Contact person for scientific queries
Name 144288 0
Thomas Papior
Address 144288 0
Bundaberg Hospital, PO Box 34, Bundaberg, QLD 4670
Country 144288 0
Australia
Phone 144288 0
+61 0741502222
Fax 144288 0
Email 144288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.