Clinical Trial: Propofol Injection for Daily Headache

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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


Detailed Summary:

Chronic daily headache (CDH) is a common and extremely disabling pain syndrome with a recent estimated point prevalence of 2.98% of the general population1 Other studies estimate a prevalence of 4.1% and 4.7% with a higher prevalence in women of 9%.2,3 The condition is disabling and is a major cause of loss of function and work capacity resulting in significant personal and national economic loss4

Therapeutic options for treating chronic headache disorders are legion and diverse and there is a steady stream of publications advocating novel therapies. Pharmacological options that have been advocated include: sodium valproate, olanzapine, tricyclic and Selective Serotonin Reuptake Inhibitor antidepressants, tizanidine, butalbital, nefazodone, baclofen, prochlorperazine, intravenous lignocaine, dihydroergotamine, opioids, monoamine oxidase inhibitors, triptans, botulinum toxin, cryotherapy and analgesic withdrawal5-20 There is much debate as to why headache treatments fail and it is proposed that the choice of an inappropriate agent is a significant reason in some patients21

On the basis of a small number of studies intravenous propofol has now been advocated for the treatment of chronic daily headache22-24 It seems fair to conclude that the existing strife to promote propofol as an effective intervention for treating CDH in the absence of a randomized controlled trial merely reflects the lack of a single good treatment option for this condition. It is, furthermore, reasonable to speculate that the beneficial effect seen with propofol is a placebo response. Krusz et al reports the effects of subanesthetic doses of intravenous propofol on chronic migraine in a cohort of 77 subjects in an open-label study22 Propofol was administered by intermittent boluses; the average dose used was 110mg. It is reported that 63 out of 77 patie
Sponsor: University of Alberta

Current Primary Outcome:

  • 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • • 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


Information By: University of Alberta

Dates:
Date Received: September 23, 2005
Date Started: September 2004
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017