EMLA and Sterile Water Injections - Pain From Injections

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02213185
• Date of registration: 07/08/2014
• Prospective Registration: Yes
• Primary sponsor: University of Skövde
• Public title: EMLA and Sterile Water Injections - Pain From Injections
• Scientific title: Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial
• Date of first enrolment: September 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02213185
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Lena B Mårtensson, Professor
• Affiliation: University of Skövde

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Other: EMLA patches

Primary Outcome(s)

Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections [Time Frame: 15 minutes]

Secondary Outcome(s)

Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections [Time Frame: 24 hours]

Secondary ID(s)

O-9-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors