Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache
Status:
Unknown status
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
: Headaches are a common complaint presenting to the emergency department (ED), accounting
for 1-2% of all ED visits, with migraines as the second most common primary headache
syndrome. Patients that ultimately present to the ED have failed outpatient therapy and
exhibit severe and persistent symptoms. Treatment options have been traditionally with a
parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions
like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted
serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as
standard therapy in the treatment of migrainne headache in the ED. Today, there are a number
of nonopioid treatment options, but not without their own individual concerns. Ergotamine and
dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is
expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in
patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used
as an anti-emetic agent, has been widely studied for use with acute migraines. Its side
effects include drowsiness and dystonic reactions. Compazine has been successfully used to
treat migraine headaches for the past several decades, and has been accepted as standard
treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects,
dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have
no addictive properties, few side effects, quick onset, be highly effective and have a low
rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of
neuropetides, which have been implicated in migraine. Native somatostatin is an unstable
compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer
half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the
acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches
associated with growth hormone secreting tumor has been established. 4 Five somatostatin
receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The
distribution of sst2 within the central nervous system strongly suggests that this particular
somatostatin receptor has a role in cranial nociception, being highly expressed in the
trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double
blind study comparing octreotide to placebo in treating migraine. They found there to be a
significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo
(76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete
relief compared to no patients in the placebo group. They went on to note that those patients
in the octreotide group had earlier relief of symptoms and no side effects. The only minor
adverse event related to the administration of octreotide was a local reaction in 3 patients
(18%). In a study performed recently in Netherlands, no clinically relevant changes in vital
signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram
analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h
after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a
double blinded study but found no difference. This was a poorly designed study, in that the
patients treated themselves at home with an injection of either placebo or octreotide for 2
episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also
performed a double blind study comparing octreotide to placebo, but looking at cluster
headaches rather than migraines. They found there to be a significant improvement with the
use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of
100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.