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Completed

NCT Number: NCT02213185

EMLA and Sterile Water Injections - Pain From Injections

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Sciences, University of Skövde

Skövde, SE-541 28, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMLA patches

Other

EMLA patches 1.5 hrs before sterile water injections

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Skövde

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2014
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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