Regions Hospital
Saint Paul, Minnesota, 55101, United States
NCT Number: NCT03066622
This trial is a prospective, randomized, feasibility trial with the primary aim of comparing how well oral rapidly dissolving olanzapine controls primary headache pain when compared to the current treatment strategies used in emergency departments which often require intravenous or intramuscular medications.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Saint Paul, Minnesota, 55101, United States
Primary Question:
Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute headache of non-organic origin (primary headache) who come to the ED for abortive therapy when compared to current standard of care?
Secondary Aim:
Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1) duration of ED length of stay and 2) need for IV access when compared to the current standard of care.
This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are randomized to standard of care medication (as determined by attending physician)
Other names: standard of care
5mg rapidly dissolving olanzapine
Other names: Zydis
Time frame: baseline, 30, 60, and 90 minutes post drug administration
Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable.
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
The total time the patient spent in the ED after initially being seen by the physician
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Determining if patients randomized to rapidly dissolving Olanzapine eventually require IV access, defined as A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture
HealthPartners Institute
Other
Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
Acronym: Olanzapine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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