Propofol Injection for Daily Headache

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00228267
First received: September 23, 2005
Last updated: November 5, 2007
Last verified: November 2007
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228267

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

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00228267     History of Changes
Other Study ID Numbers: SR 001
Study First Received: September 23, 2005
Last Updated: November 5, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Headache
Headache Disorders
Headache Disorders, Secondary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 02, 2014