Skip to content

Propofol Injection for Daily Headache

CompletedPhase 2NCT00228267
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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

Study details

Official title
The Effect of Single-dose Propofol Injection on Pain and Quality of Life in Chronic Daily Headache: a Randomized Double-blind Controlled Trial
Conditions
  • Chronic Headache
  • Analgesic Rebound Headache
  • Chronic Daily Headache
  • Headache, Intractable
Interventions
Sponsor
University of Alberta
Start date
2004-09
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Canadian sites (1)

FacilityCityProvince
Multidisciplinary Pain Centre, Univ. Alta HospitalEdmontonAlberta

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00228267