None listed
Conditions
Brief summary
300,000 Canadians a year visit an emergency department (ED) for headache. Most causes are primary headaches (i.e. not dangerous or benign). The main ED care is providing pain relief. This is often delayed given the state of crowding, the inability to take oral medications due to accompanying nausea/vomiting and the slow onset of oral medications. Most patients receive intravenous (IV) treatments which are usually delayed due to the need to have an IV started. An alternative is local anesthetic lidocaine intranasally to freeze the sphenopalatine nerve ganglion which is just under the mucosa surface. This ganglion is important in the process of pain and likely to stop a headache within minutes of administration. Intranasal lidocaine may reduce time to analgesia, decreasing patients’ pain and the time spent in the ED. A well-designed clinical trial is necessary to determine if a sphenopalatine ganglion block is effective for benign headache patients. Sphenopalatine ganglion blocks could be administered early. Standard treatments require IV access and are delayed, usually after physician assessment. The goal of this pilot trial will determine the feasibility and design of such a clinical trial.
Interventions
The intervention is bilateral 2% lidocaine intranasal drops (2ml/side) over 30 seconds, targeting the sphenopalatine ganglion. The comparator is intranasal placebo utilizing saline.
The treating physician will administer the intranasal drops. The Research Assistant will observe the administration of the intranasal drops, verifying if it has been administered correctly.
Sponsors
The Ottawa Hospital Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults ( greater than or equal to 18 years) with a primary headache, • with pain involving the peri or retro-orbital area, • likely to be discharged from the ED after symptom relief as determined by the treating physician.
Exclusion criteria
a) Under the age of 18 b) ED physician suspects a serious headache (e.g. meningitis, subarachnoid hemorrhage) c) Allergy to local anesthetics (e.g. lidocaine) d) Cranial surgery in the last 6 months e) History of ventriculoperitoneal (VP) shunt, brain tumor, or aneurysm f) Inability to provide consent g) Pain is excluding the peri- and retro-orbital area (patients with other areas of pain in addition to this area are not excluded). h) Physician has already administered an SPG block
Outcome results
None listed