EMLA and Sterile Water Injections - Pain From Injections

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: EMLA patches

• Registration Number: NCT02213185
• Lead Sponsor: University of Skövde

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.

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-11
• Study Start: 2014-09
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA patches and isotonic saline	EMLA patches	EMLA patches 1.5 hrs before isotonic saline
Placebo patches and isotonic saline	EMLA patches	PLACEBO patches 1.5 hrs before isotonic saline
EMLA patches and SWI	EMLA patches	EMLA patches 1.5 hrs before sterile water injections
Placebo patches and SWI	EMLA patches	PLACEBO patches 1.5 hrs before sterile water injections

Primary Outcome Measures

Name	Time	Method
Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections	15 minutes	Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain

Secondary Outcome Measures

Name	Time	Method
Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections	24 hours	Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections

Trial Locations

Locations (1)

School of Health Sciences, University of Skövde; 🇸🇪 Skövde, Sweden