Sterile Water Injections for Relieving Ureterolithiasis Pain

Sponsor

University of Skövde (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01412840

Collaborator

(none)

Enrollment

Location

Arms

107

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureterolithiasis Pain	Other: Diclofenac and sterile water injections Other: Diclofenac and isotonic saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard care 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.	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.
Placebo Comparator: Standard care 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.	Other: 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.
No Intervention: Standard care The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac.

Arm

Intervention/Treatment

Experimental: Standard care 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.

Other: Diclofenac and sterile water injections

Placebo Comparator: Standard care 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.

Other: Diclofenac and isotonic saline

No Intervention: Standard care

The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Life Sciences, University of Skövde	Skövde		Sweden	SE-541 28

Sponsors and Collaborators

University of Skövde

Investigators

Principal Investigator: Ingrid Bergh, PhD, University of Skövde

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lena B Martensson, Associate Professor, University of Skövde

ClinicalTrials.gov Identifier:

NCT01412840

Other Study ID Numbers:

787-08

First Posted:

Aug 9, 2011

Last Update Posted:

Apr 19, 2019

Last Verified:

Apr 1, 2019

Keywords provided by Lena B Martensson, Associate Professor, University of Skövde

Additional relevant MeSH terms:

Ureterolithiasis

Ureteral Calculi

Diclofenac

Study Results

No Results Posted as of Apr 19, 2019