Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache

What Was Tested

In this phase 4 trial, researchers set out to test Cosyntropin.

PDPH is a common problem after either intentional or unintentional Dural puncture.

It is especially common in young female patients and in patients undergoing Lumbar Puncture using the typical kit containing large 20 gauge needles (1).

It had two arms (groups): Intravenous Cosyntropin Group A (experimental) and Epidural Blood Patch Group B (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

After patients receive and sign an informed consent form (ICF) Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or (2)Cosyntropin IV with IVF therapy.

Endpoints will be a pain score that is given prior to the procedure, ED discharge pain score and post procedural day (PPD) day 1, day 3 and day 7 pain and functional levels.

Investigational New Drug (IND) Exemption for use of Cosyntropin.

Methods and Materials: After referral to an Anesthesiologist and confirmation of PDPH diagnosis, patient will be randomized to either Cosyntropin or Epidural Blood Patch assuring they are negative for pregnancy.

Who Took Part

The registry lists 29 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years of age or older,. Diagnosed by Anesthesia provider as having PDPH. Agrees to participation in study.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patient's contraindication to ebp: local infection at injection site, systemic infection, hemodynamically unstable, severely hypovolemic; patient's contraindication to ebp: known or past reaction to natural acth or cosyntropin; signs or symptoms of icp such as mental status changes, bradycardia and hypertension.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Cosyntropin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cosyntropin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Cosyntropin, so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2010-08 with completion listed for 2014-04.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Headache Pain Score (time frame: 1 day post procedure). Headache Pain Score (time frame: 3 days post procedure). Headache Pain Score (time frame: 7 days post procedure).

It also tracked 3 secondary outcomes, for example Functioning Score, Functioning Score and Functioning Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cosyntropin in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cosyntropin compound page, all human trials.