Sterile Water Injections for Relieving Ureterolithiasis Pain

Not Applicable

Withdrawn

• Conditions: Ureterolithiasis; Pain
• Interventions: Other: Diclofenac and sterile water injections; Other: Diclofenac and isotonic saline

• Registration Number: NCT01412840
• Lead Sponsor: University of Skövde

Brief Summary

Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2014-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ureterolithiasis pain, acute onset,
• Requires pain relief,
• Standard treatment prescribed,
• Age 18-60,
• Ability to understand and follow instructions

Exclusion Criteria

• Other administration of NSAID for analgesia 12 hours prior to intervention,
• Pregnancy with obstructed flow of urine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care and sterile water injections	Diclofenac and sterile water injections	The patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain.
Standard care and isotonic saline	Diclofenac and isotonic saline	The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain.

Primary Outcome Measures

Name	Time	Method
Change in experience of pain	VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment	Measurement tool: Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Requirement for additional pain relief	Reported in the protocol up to two hours after treatment	The staff will reporter if any additional pain relief treatment have been used

Trial Locations

Locations (1)

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