Sterile Water Injections for Relieving Ureterolithiasis Pain

NCT ID: NCT01412840

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diclofenac and sterile water injections

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

Diclofenac and isotonic saline

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Skövde

OTHER

Sponsor Role: lead

Responsible Party

Lena B Martensson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid Bergh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Skövde

Locations

School of Life Sciences, University of Skövde

Skövde, , Sweden

Countries

Sweden

Other Identifiers

787-08

Identifier Type: -

Identifier Source: org_study_id