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Sterile Water Injections for Relieving Ureterolithiasis Pain

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ClinicalTrials.gov Identifier: NCT01412840
Recruitment Status : Active, not recruiting
First Posted : August 9, 2011
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Lena B Martensson, 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.

Condition or disease Intervention/treatment Phase
Ureterolithiasis Pain Other: Diclofenac and sterile water injections Other: Diclofenac and isotonic saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : August 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change in experience of pain [ Time Frame: 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 :
  1. Requirement for additional pain relief [ Time Frame: Reported in the protocol up to two hours after treatment ]
    The staff will reporter if any additional pain relief treatment have been used



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412840


Locations
Sweden
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

Responsible Party: Lena B Martensson, Associate Professor, University of Skövde
ClinicalTrials.gov Identifier: NCT01412840     History of Changes
Other Study ID Numbers: 787-08
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Lena B Martensson, University of Skövde:
Ureterolithiasis
Pain
Complementary
RCT

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