Sterile Water Injections for Relieving Ureterolithiasis Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Skövde
Sponsor:
Information provided by (Responsible Party):
Lena Martensson, University of Skövde
ClinicalTrials.gov Identifier:
NCT01412840
First received: November 24, 2010
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention
Ureterolithiasis
Pain
Other: Diclofenac and sterile water injections
Other: Diclofenac and isotonic saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Skövde:

Primary Outcome Measures:
  • Change in experience of pain [ Time Frame: VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment ] [ Designated as safety issue: No ]
    Measurement tool: Visual Analogue Scale (VAS)


Secondary Outcome Measures:
  • Requirement for additional pain relief [ Time Frame: Reported in the protocol up to two hours after treatment ] [ Designated as safety issue: No ]
    The staff will reporter if any additional pain relief treatment have been used


Estimated Enrollment: 90
Study Start Date: August 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412840

Contacts
Contact: Ingrid Bergh, PhD +46 500 44 80 00 ext 8452 ingrid.bergh@his.se
Contact: Lena B Mårtensson, PhD +46 500 44 80 00 ext 8450 lena.martensson@his.se

Locations
Sweden
School of Life Sciences, University of Skövde Active, not recruiting
Skövde, Sweden, SE-541 28
Sponsors and Collaborators
University of Skövde
Investigators
Principal Investigator: Ingrid Bergh, PhD University of Skövde
  More Information

No publications provided

Responsible Party: Lena Martensson, Associate Professor, University of Skövde
ClinicalTrials.gov Identifier: NCT01412840     History of Changes
Other Study ID Numbers: 787-08
Study First Received: November 24, 2010
Last Updated: August 7, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Skövde:
Ureterolithiasis
Pain
Complementary
RCT

Additional relevant MeSH terms:
Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urinary Calculi
Urolithiasis
Urologic Diseases
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014