Back to resultsSterile Water Injections for Relieving Ureterolithiasis Pain
Primary Purpose
Ureterolithiasis, Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Diclofenac and sterile water injections
Diclofenac and isotonic saline
Sponsored by
About this trial
This is an interventional treatment trial for Ureterolithiasis focused on measuring Ureterolithiasis, Pain, Complementary, RCT
Eligibility Criteria
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
Sites / Locations
- School of Life Sciences, University of Skövde
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Standard care and sterile water injections
Standard care and isotonic saline
Standard care
Arm Description
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.
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.
The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac.
Outcomes
Primary Outcome Measures
Change in experience of pain
Measurement tool: Visual Analogue Scale (VAS)
Secondary Outcome Measures
Requirement for additional pain relief
The staff will reporter if any additional pain relief treatment have been used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01412840
Brief Title
Sterile Water Injections for Relieving Ureterolithiasis Pain
Official Title
Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Skövde
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiasis, Pain
Keywords
Ureterolithiasis, Pain, Complementary, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care and sterile water injections
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care and isotonic saline
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac.
Intervention Type
Other
Intervention Name(s)
Diclofenac and sterile water injections
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diclofenac and isotonic saline
Intervention Description
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 Measure Information:
Title
Change in experience of pain
Description
Measurement tool: Visual Analogue Scale (VAS)
Time Frame
VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment
Secondary Outcome Measure Information:
Title
Requirement for additional pain relief
Description
The staff will reporter if any additional pain relief treatment have been used
Time Frame
Reported in the protocol up to two hours after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Bergh, PhD
Organizational Affiliation
University of Skövde
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Life Sciences, University of Skövde
City
Skövde
ZIP/Postal Code
SE-541 28
Country
Sweden
12. IPD Sharing Statement
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Sterile Water Injections for Relieving Ureterolithiasis Pain
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