Sterile Water Injections for Relieving Ureterolithiasis Pain

University of Skövde

Status: Withdrawn

Conditions: Ureterolithiasis; Pain

Treatments: Other: Diclofenac and sterile water injections; Other: Diclofenac and isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01412840

787-08

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Standard care and sterile water injections

Experimental group

Description:

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.

Treatment:

Other: Diclofenac and sterile water injections

Standard care and isotonic saline

Placebo Comparator group

Description:

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.

Treatment:

Other: Diclofenac and isotonic saline

Standard care

No Intervention group

Description:

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