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Propofol Injection for Daily Headache

This study has been completed.
Information provided by (Responsible Party):
Saifudin Rashiq, University of Alberta Identifier:
First received: September 23, 2005
Last updated: May 2, 2017
Last verified: May 2017

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

Condition Intervention Phase
Chronic Headache Analgesic Rebound Headache Chronic Daily Headache Headache, Intractable Drug: Propofol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Saifudin Rashiq, University of Alberta:

Primary Outcome Measures:
  • Headache Disability Index and the Headache Index
  • The baseline Headache Index is the mean of all 28 NRS pain scores (four measures daily for seven days) and the post-treatment Headache Index is the mean of all 120 NRS pain scores (four measures daily for thirty days)

Secondary Outcome Measures:
  • Number of days with a headache of at least moderate severity defined as pain at least 5 on the Numerical Rating Scale (NRS).
  • Peak daily headache severity according to the NRS.
  • Analgesic medication consumption will be measured in terms of morphine equivalents of narcotic medication and number of tablets /doses of acetaminophen / non-steroidal anti-inflammatory (NSAID) containing analgesics.53
  • Visits to the Emergency Room for headache treatment.
  • Sedation and nausea scores in the treatment and placebo groups.
  • Ability of participants in each of the groups to correctly guess their treatment assignment.
  • Adverse effects related to the infusion

Estimated Enrollment: 28
Study Start Date: September 2004
Study Completion Date: November 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00228267

Canada, Alberta
Multidisciplinary Pain Centre, Univ. Alta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Mark K Simmonds, MD University of Alberta
  More Information

Additional Information:
Responsible Party: Saifudin Rashiq, Anesthesiologist, University of Alberta Identifier: NCT00228267     History of Changes
Other Study ID Numbers: SR 001
Study First Received: September 23, 2005
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Saifudin Rashiq, University of Alberta:
Chronic Headache
Analgesic Rebound Headache
Chronic Daily Headache
Headache, Intractable
Randomised controlled trial

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Secondary
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on September 21, 2017