Status:
COMPLETED
Propofol Injection for Daily Headache
Lead Sponsor:
University of Alberta
Conditions:
Chronic Headache
Analgesic Rebound Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality of life for the next 30 days in persons with chronic daily headache (CDH) Specific objectives To measure th...
Detailed Description
Chronic daily headache (CDH) is a common and extremely disabling pain syndrome with a recent estimated point prevalence of 2.98% of the general population1 Other studies estimate a prevalence of 4.1% ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adult subjects (18-65 years) with CDH by the criteria of Silberstein and Lipton.41 i.e. on the basis of pre-randomization history suffer chronic headaches lasting more than 4 hours a day for more than 15 days a month.
- Previously investigated to exclude serious treatable pathology.
- On the basis of the pre-randomization headache diary: the average pain intensity during each episode should be at least 5 /10 on the Numerical Rating Scale (NRS) on 4 days out of 7.
- Quality of life and function should be impaired as evidenced by a (pre-randomization) Headache Disability Index (HDI) of at least 40.
- Exclusion criteria
- History of the following:
- Known or suspected allergy to propofol, intralipid or midazolam,
- In emergency or life-threatening situations,
- Those having language barriers (e.g. illiterate, not English-speaking, dysphasic),
- Known or suspected difficult airway or sleep apnea,
- Severe respiratory disease,
- Neuromuscular disease,
- Seizure disorder,
- Severe cardiac disease,
- Severe gastroesophageal reflux disease,
- Pancreatitis,
- Lipid disorders,
- Receiving Total Parenteral Nutrition,
- Body mass index \> 35, diabetes or major endocrine disorder,
- Hepatic or renal failure,
- Unstable psychiatric disorder,
- Known drug abuse,
- Pregnancy,
- Cognitively impaired.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00228267
Start Date
September 1 2004
End Date
November 1 2007
Last Update
May 4 2017
Active Locations (1)
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1
Multidisciplinary Pain Centre, Univ. Alta Hospital
Edmonton, Alberta, Canada, T6G 2B7