Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache

What Was Tested

The trial (phase 1, phase 2) is built around Octreotide for migraine.

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.

The registry classes the interventions as drug.

More on the Plan

A urine pregnancy test will be performed on women of child bearing age.

After informed consent is obtained, each patient will be placed in a dark private room and asked to grade nausea, pain, and sedation on a 10 cm visual analog scale, using the left end as the zero point for complaints and measurements.

Patients will be instructed that a score of zero signifies no pain and a score of 10 indicates severe pain.

Each patient will be monitored with continous pulse oximetry and have a 20-gauge IV catheter placed in the antecubital fossa.

Who Took Part

Enrollment: 56 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: pregnancy and lactation,; pre-medication within six hours of being enrolled in the study,; more than six prior headaches per month,.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the migraine participants and researchers unaware of who received Octreotide.

It started in 2006-01 with completion listed for 2007-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Patient Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Octreotide in 56 people with migraine.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Migraine research.