Sterile Water Injections for Relieving Ureterolithiasis Pain

Pain Clinical Trial

Official title:

Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01412840
• Other study ID #: 787-08
• Status: Withdrawn
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: April 2019
• Source: University of Skövde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Ureteral Calculi
• Ureterolithiasis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	School of Life Sciences, University of Skövde	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
University of Skövde

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in experience of pain	Measurement tool: Visual Analogue Scale (VAS)	VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment
Secondary	Requirement for additional pain relief	The staff will reporter if any additional pain relief treatment have been used	Reported in the protocol up to two hours after treatment