EMLA and Sterile Water Injections - Pain From Injections
Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile water injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Sep 2014
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedJanuary 22, 2020
January 1, 2020
5.3 years
August 7, 2014
January 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
24 hours
Study Arms (4)
EMLA patches and SWI
EXPERIMENTALEMLA patches 1.5 hrs before sterile water injections
EMLA patches and isotonic saline
ACTIVE COMPARATOREMLA patches 1.5 hrs before isotonic saline
Placebo patches and SWI
PLACEBO COMPARATORPLACEBO patches 1.5 hrs before sterile water injections
Placebo patches and isotonic saline
PLACEBO COMPARATORPLACEBO patches 1.5 hrs before isotonic saline
Interventions
EMLA patches 1.5 hrs before sterile water injections
Eligibility Criteria
You may qualify if:
- Woman
- Age 18-45 years
- Healthy
- Ability to understand information and instructions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Health Sciences, University of Skövde
Skövde, SE-541 28, Sweden
Related Publications (1)
Martensson LB, Gunnarsson BM, Karlsson S, Lee N, Bergh I. Effect of topical local anaesthesia on injection pain associated with administration of sterile water injections - a randomized controlled trial. BMC Anesthesiol. 2022 Feb 1;22(1):35. doi: 10.1186/s12871-022-01573-0.
PMID: 35105307DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lena B Mårtensson, Professor
University of Skövde
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
September 1, 2014
Primary Completion
December 18, 2019
Study Completion
December 18, 2019
Last Updated
January 22, 2020
Record last verified: 2020-01