Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

Study Overview
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Brief Summary
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The primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23G hypodermic needle.

Detailed Description
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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.

Official Title
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Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study

Conditions
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Pain

Intervention / Treatment
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* Device: Standard needle BBraun Sterican® 23G and 25mm in length
* Device: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 21 Exclusion Criteria: concurrent antipyretic use in the last 24 hrs, presence of painful conditions eg fracture, rheumatoid arthritis history of peripheral vascular disease

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Arterial puncture with an insulin syringe followed by arterial puncture with standard needle. | Device: Standard needle BBraun Sterican® 23G and 25mm in length<br>* Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.<br>Device: Insulin<br>* Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)<br>|
| Active Comparator: Standard<br>Arterial puncture with standard needle followed by arterial puncture with insulin syringe. | Device: Standard needle BBraun Sterican® 23G and 25mm in length<br>* Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.<br>Device: Insulin<br>* Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) score in millimetres | Immediately following the radial arterial punctures the outcome assessor asked the volunteer to assess the discomfort that was caused by the puncture. The volunteer was asked to place a slash on a 100 mm VAS sheet. The VAS showed no pain at 0 mm and worst pain at 100 mm. | Immediately after each puncture ( average within 5 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood haemolysis | The serum collected during the punctures was analysed for the amount of free haemoglobin. We define presence of haemolysis as free haemoglobin concentration of more than 100 mg/dL. | Immediately after collection |