EMLA and Sterile Water Injections - Pain From Injections

NCT ID: NCT02213185

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EMLA patches and SWI

EMLA patches 1.5 hrs before sterile water injections

Group Type EXPERIMENTAL

EMLA patches

Intervention Type OTHER

EMLA patches 1.5 hrs before sterile water injections

EMLA patches and isotonic saline

EMLA patches 1.5 hrs before isotonic saline

Group Type ACTIVE_COMPARATOR

EMLA patches

Intervention Type OTHER

EMLA patches 1.5 hrs before sterile water injections

Placebo patches and SWI

PLACEBO patches 1.5 hrs before sterile water injections

Group Type PLACEBO_COMPARATOR

EMLA patches

Intervention Type OTHER

EMLA patches 1.5 hrs before sterile water injections

Placebo patches and isotonic saline

PLACEBO patches 1.5 hrs before isotonic saline

Group Type PLACEBO_COMPARATOR

EMLA patches

Intervention Type OTHER

EMLA patches 1.5 hrs before sterile water injections

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EMLA patches

EMLA patches 1.5 hrs before sterile water injections

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Skövde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lena B Martensson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lena B Mårtensson, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Skövde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Health Sciences, University of Skövde

Skövde, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35105307 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

O-9-2013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ice Versus EMLA for Pain in Laser Hair Removal
NCT02318654 ACTIVE_NOT_RECRUITING PHASE4
Efficacy of a New Topical Anesthetic
NCT00562211 COMPLETED PHASE1/PHASE2
EMLA Cream in Hysteroscopy Practice
NCT02640183 UNKNOWN PHASE2