EMLA and Sterile Water Injections - Pain From Injections

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213185
• Other study ID #: O-9-2013
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 18, 2019

Study information

• Verified date: January 2020
• Source: University of Skövde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Pain

Intervention

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

Locations

Country	Name	City	State
Sweden	School of Health Sciences, University of Skövde	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
University of Skövde

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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