PainNCT02213185
EMLA and Sterile Water Injections - Pain From Injections
A study testing EMLA patches in people with Pain, run by University of Skövde at 1 site in Sweden.
Trial summary
The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile water injections. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- EMLA patches
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman
- Age 18-45 years
- Healthy
- Ability to understand information and instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- EMLA patches
- Keywords
- Sterile water injections, Pain, VAS, Complementary method
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA patchesOther
EMLA patches 1.5 hrs before sterile water injections
| Study group | Role | What they receive |
|---|---|---|
| EMLA patches and SWI | Experimental | EMLA patches 1.5 hrs before sterile water injections Receives: Other: EMLA patches |
| EMLA patches and isotonic saline | Active comparator | EMLA patches 1.5 hrs before isotonic saline Receives: Other: EMLA patches |
| Placebo patches and SWI | Placebo comparator | PLACEBO patches 1.5 hrs before sterile water injections Receives: Other: EMLA patches |
| Placebo patches and isotonic saline | Placebo comparator | PLACEBO patches 1.5 hrs before isotonic saline Receives: Other: EMLA patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Skövde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena B Martensson, University of Skövde
- Investigators
- Lena B Mårtensson, Professor, Principal investigator, University of Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213185
- Sponsor's protocol ID
- O-9-2013
- Status last verified
- Jan 2020
- First submitted
- 7 Aug 2014
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35105307
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02213185
- Acronym / sponsor ID
- O-9-2013
- Conditions
- Pain
- Keywords
- Sterile water injections, Pain, VAS, Complementary method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SkövdeUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EMLA patches and SWI | Experimental | Other: EMLA patchesEMLA patches 1.5 hrs before sterile water injections |
| EMLA patches and isotonic saline | Active comparator | Other: EMLA patchesEMLA patches 1.5 hrs before isotonic saline |
| Placebo patches and SWI | Placebo comparator | Other: EMLA patchesPLACEBO patches 1.5 hrs before sterile water injections |
| Placebo patches and isotonic saline | Placebo comparator | Other: EMLA patchesPLACEBO patches 1.5 hrs before isotonic saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman
- Age 18-45 years
- Healthy
- Ability to understand information and instructions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLA patchesEMLA patches 1.5 hrs before sterile water injections | Other | EMLA patches and SWI, EMLA patches and isotonic saline, Placebo patches and SWI, Placebo patches and isotonic saline |
Primary outcome
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
1 secondary outcome
Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 35105307Martensson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena B Mårtensson, Professor principal investigator
University of Skövde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA patches in people with Pain, run by University of Skövde at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.