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EMLA and Sterile Water Injections - Pain From Injections

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ClinicalTrials.gov Identifier: NCT02213185
Recruitment Status : Recruiting
First Posted : August 11, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lena B Martensson, University of Skövde

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

Condition or disease Intervention/treatment Phase
Pain Other: EMLA patches Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213185


Contacts
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Contact: Lena B Mårtensson, Professor +46500 44 80 00 ext 8450 lena.martensson@his.se
Contact: Ingrid Bergh, Professor +46500 44 80 00 ext 8452 ingrid.bergh@his.se

Locations
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Sweden
School of Health and Education, University of Skövde Recruiting
Skövde, Sweden, SE-541 28
Contact: Ingrid Bergh, PhD    +46 500 44 80 00 ext 8452    ingrid.bergh@his.se   
Contact: Lena B Mårtensson, PhD    +46 500 44 80 00 ext 8450    lena.martensson@his.se   
Principal Investigator: Ingrid Bergh, PhD         
Sub-Investigator: Lena B Mårtensson, PhD         
Sponsors and Collaborators
University of Skövde
Investigators
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Principal Investigator: Lena B Mårtensson, Professor University of Skövde

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Responsible Party: Lena B Martensson, Professor, University of Skövde
ClinicalTrials.gov Identifier: NCT02213185     History of Changes
Other Study ID Numbers: O-9-2013
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lena B Martensson, University of Skövde:
Sterile water injections
Pain
VAS
Complementary method
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined