EMLA and Sterile Water Injections - Pain From Injections

January 18, 2020 updated by: Lena B Martensson, University of Skövde

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Skövde, Sweden, SE-541 28
        • School of Health Sciences, University of Skövde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Skövde

Investigators

  • Principal Investigator: Lena B Mårtensson, Professor, University of Skövde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 18, 2019

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 18, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O-9-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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