NCT00228267

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

First QC Date

September 23, 2005

Last Update Submit

May 2, 2017

Conditions

Chronic HeadacheAnalgesic Rebound HeadacheChronic Daily HeadacheHeadache, Intractable

Keywords

Chronic HeadacheAnalgesic Rebound HeadacheChronic Daily HeadacheHeadache, IntractableRandomised controlled trialPropofol

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Interventions

PropofolDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multidisciplinary Pain Centre, Univ. Alta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

  • Simmonds MK, Rashiq S, Sobolev IA, Dick BD, Gray DP, Stewart BJ, Jamieson-Lega KI. The effect of single-dose propofol injection on pain and quality of life in chronic daily headache: a randomized, double-blind, controlled trial. Anesth Analg. 2009 Dec;109(6):1972-80. doi: 10.1213/ANE.0b013e3181be3f86.

    PMID: 19923528RESULT

Related Links

MeSH Terms

Conditions

Headache DisordersHeadache Disorders, Secondary

Interventions

Propofol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mark K Simmonds, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 28, 2005

Study Start

September 1, 2004

Study Completion

November 1, 2007

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)