EMLA and Sterile Water Injections – Pain From Injections

Overview

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

Full Title of Study: “Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections – a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 18, 2019

Detailed Description

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.

Interventions

  • Other: EMLA patches
    • EMLA patches 1.5 hrs before sterile water injections

Arms, Groups and Cohorts

  • Experimental: EMLA patches and SWI
    • EMLA patches 1.5 hrs before sterile water injections
  • Active Comparator: EMLA patches and isotonic saline
    • EMLA patches 1.5 hrs before isotonic saline
  • Placebo Comparator: Placebo patches and SWI
    • PLACEBO patches 1.5 hrs before sterile water injections
  • Placebo Comparator: Placebo patches and isotonic saline
    • PLACEBO patches 1.5 hrs before isotonic saline

Clinical Trial Outcome Measures

Primary Measures

  • Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections
    • Time Frame: 15 minutes
    • Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain

Secondary Measures

  • Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
    • Time Frame: 24 hours
    • Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Skövde
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lena B Martensson, Professor – University of Skövde
  • Overall Official(s)
    • Lena B Mårtensson, Professor, Principal Investigator, University of Skövde

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