EMLA and Sterile Water Injections - Pain From Injections

Study Overview
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Brief Summary
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The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile water injections.

Detailed Description
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Sterile Water Injection (SWI) was previously shown to give good pain relief for lower-back pain during childbirth, chronic neck pain and ureterolithiasis. However, the pain associated with the injections remains problematic, and therefore it is important to find a less painful injection technique.

Official Title
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Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Other: EMLA patches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Woman Age 18-45 years Healthy Ability to understand information and instructions Exclusion Criteria: Pregnancy Previous experience of SWI On-going pain Use of medication for depression, pain, or sleeping disorder 24 hours prior to the experiment Smoking, snuffing, physical activity, and intake of caffeinated beverages (coffee, tea, or energy drink (e.g., Red Bull) 2 hours prior to the experiment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMLA patches and SWI<br>EMLA patches 1.5 hrs before sterile water injections | Other: EMLA patches<br>* EMLA patches 1.5 hrs before sterile water injections<br>|
| Active Comparator: EMLA patches and isotonic saline<br>EMLA patches 1.5 hrs before isotonic saline | Other: EMLA patches<br>* EMLA patches 1.5 hrs before sterile water injections<br>|
| Placebo Comparator: Placebo patches and SWI<br>PLACEBO patches 1.5 hrs before sterile water injections | Other: EMLA patches<br>* EMLA patches 1.5 hrs before sterile water injections<br>|
| Placebo Comparator: Placebo patches and isotonic saline<br>PLACEBO patches 1.5 hrs before isotonic saline | Other: EMLA patches<br>* EMLA patches 1.5 hrs before sterile water injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections | Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections | Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sterile water injections, Pain, VAS, Complementary method