Back to resultsEMLA and Sterile Water Injections - Pain From Injections
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
EMLA patches
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Sterile water injections, Pain, VAS, Complementary method
Eligibility 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
Sites / Locations
- School of Health Sciences, University of Skövde
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
EMLA patches and SWI
EMLA patches and isotonic saline
Placebo patches and SWI
Placebo patches and isotonic saline
Arm Description
EMLA patches 1.5 hrs before sterile water injections
EMLA patches 1.5 hrs before isotonic saline
PLACEBO patches 1.5 hrs before sterile water injections
PLACEBO patches 1.5 hrs before isotonic saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02213185
Brief Title
EMLA and Sterile Water Injections - Pain From Injections
Official Title
Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Skövde
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile water injections.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Sterile water injections, Pain, VAS, Complementary method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMLA patches and SWI
Arm Type
Experimental
Arm Description
EMLA patches 1.5 hrs before sterile water injections
Arm Title
EMLA patches and isotonic saline
Arm Type
Active Comparator
Arm Description
EMLA patches 1.5 hrs before isotonic saline
Arm Title
Placebo patches and SWI
Arm Type
Placebo Comparator
Arm Description
PLACEBO patches 1.5 hrs before sterile water injections
Arm Title
Placebo patches and isotonic saline
Arm Type
Placebo Comparator
Arm Description
PLACEBO patches 1.5 hrs before isotonic saline
Intervention Type
Other
Intervention Name(s)
EMLA patches
Intervention Description
EMLA patches 1.5 hrs before sterile water injections
Primary Outcome Measure Information:
Title
Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections
Description
Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
Description
Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena B Mårtensson, Professor
Organizational Affiliation
University of Skövde
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Sciences, University of Skövde
City
Skövde
ZIP/Postal Code
SE-541 28
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35105307
Citation
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.
Results Reference
derived
Learn more about this trial
EMLA and Sterile Water Injections - Pain From Injections
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