Sterile Water Injections for Relieving Ureterolithiasis Pain

NCT01412840 | Withdrawn

• 1 other identifier: 787-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureterolithiasis; Pain

Keywords

Ureterolithiasis; Pain; Complementary; RCT

Outcome Measures

Primary Outcomes (1)

• Change in experience of pain

  Measurement tool: Visual Analogue Scale (VAS)

  VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment

Secondary Outcomes (1)

• Requirement for additional pain relief

  Reported in the protocol up to two hours after treatment

Study Arms (3)

Standard care and sterile water injections

EXPERIMENTAL

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

Standard care and isotonic saline

PLACEBO COMPARATOR

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

Standard care

NO INTERVENTION

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

Interventions

Diclofenac and sterile water injections OTHER

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.

Standard care and sterile water injections

Diclofenac and isotonic saline OTHER

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.

Standard care and isotonic saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ureterolithiasis pain, acute onset,
• Requires pain relief,
• Standard treatment prescribed,
• Age 18-60,
• Ability to understand and follow instructions

You may not qualify if:

• Other administration of NSAID for analgesia 12 hours prior to intervention,
• Pregnancy with obstructed flow of urine

Sponsors & Collaborators

• University of Skövde: lead

Study Sites (1)

School of Life Sciences, University of Skövde

Skövde, SE-541 28, Sweden

Location

MeSH Terms

Conditions

Ureterolithiasis; Pain

Interventions

Diclofenac; Sodium Chloride

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ingrid Bergh, PhD

  University of Skövde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: August 9, 2011
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

SE (1)