Sterile Water Injections for Relieving Ureterolithiasis Pain

Overview

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.

Full Title of Study: “Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2022

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • No Intervention: Standard care
    • The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac.

Clinical Trial Outcome Measures

Primary 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
    • Measurement tool: Visual Analogue Scale (VAS)

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Skövde
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lena B Martensson, Associate Professor – University of Skövde
  • Overall Official(s)
    • Ingrid Bergh, PhD, Principal Investigator, University of Skövde

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