Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

It had two arms (groups): Insulin (experimental) and Standard (active comparator).

Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.

Arterial puncture with standard needle followed by arterial puncture with insulin syringe.

The registry classes the interventions as device.

More on the Plan

In a randomised, crossover design, healthy volunteers were recruited to receive bilateral radial arterial punctures.

They were assigned to receive either the insulin or the standard needle as the first puncture using block randomisation.

The primary outcome was the pain score measured on a 100mm visual analogue scale (VAS) and the secondary outcomes were procedural complications and rate of haemolysis.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Age above 21.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: concurrent antipyretic use in the last 24 hrs,; presence of painful conditions eg fracture, rheumatoid arthritis; history of peripheral vascular disease.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2012-05 with completion listed for 2013-03.

It ran at 1 site in Singapore.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Visual analogue scale (VAS) score in millimetres (time frame: Immediately after each puncture ( average within 5 minutes)).

It also tracked 1 secondary outcome, for example blood haemolysis.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.