Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Ketamine

Brief Summary

To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Intervention / Treatment

  • Shock wave lithotripsy (PROCEDURE)
    All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.

Condition or Disease

  • Pediatric Urinary Lithiasis

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 12 Months to 16 Years
    Enrollment: 81 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Mar 01, 2008
    Primary Completion: Feb 01, 2012 ACTUAL
    Completion Date: Jun 01, 2012 ACTUAL
    Study First Posted: Mar 08, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 06, 2013

    Sponsors / Collaborators

    Lead Sponsor: TC Erciyes University
    Responsible Party: N/A

    Location

    Talas, Turkey
    Kayseri, Talas, Turkey

    Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

    Participant Groups

    • All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.

    • All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the stepwise group, the voltage was started at 10 kV and increased stepwise (every 250 shock waves) to 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 16
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    The patients with pediatric urinary lithiasis.

    Exclusion Criteria:

    Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

    Primary Outcomes

    • The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

    Other Outcomes

    • To detect obstruction in the system, ultrasonography was used during control.

    • In case of non-opaque Stones, stone borden was evalusted with spinal computed tomography. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

    More Details

    NCT Number: NCT01807260
    Other IDs: stepwise0946
    Study URL: https://clinicaltrials.gov/study/NCT01807260
    Last updated: Sep 29, 2023