Propofol Injection for Daily Headache

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 the effect of a single infusion of propofol at 40 mcg / kg / minute over 60 mins on headache-related quality of life (measured by the Headache Disability Index) and on headache severity (measured by the Headache Index) in subjects with chronic daily headache over 30 days45-47

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Propofol

Criteria

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.