EMLA and Sterile Water Injections - Pain From Injections

University of Skövde

Status: Completed

Conditions: Pain

Treatments: Other: EMLA patches

Study type: Interventional

Funder types: Other

Identifiers

NCT02213185

O-9-2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

EMLA patches and SWI

Experimental group

Description:

EMLA patches 1.5 hrs before sterile water injections

Treatment:

Other: EMLA patches

EMLA patches and isotonic saline

Active Comparator group

Description:

EMLA patches 1.5 hrs before isotonic saline

Treatment:

Other: EMLA patches

Placebo patches and SWI

Placebo Comparator group

Description:

PLACEBO patches 1.5 hrs before sterile water injections

Treatment:

Other: EMLA patches

Placebo patches and isotonic saline

Placebo Comparator group

Description:

PLACEBO patches 1.5 hrs before isotonic saline

Treatment:

Other: EMLA patches