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Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy

Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03032458
Enrollment
165
Registered
2017-01-26
Start date
2017-01-31
Completion date
2017-10-31
Last updated
2018-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Urolithiasis

Keywords

Shock Wave Lithotripsy, Ketorolac, Xylocaine Gel, Pethidine

Brief summary

A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.

Detailed description

Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL. Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin. Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation. Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice. In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode. The investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study.

Interventions

DRUGPethidine

pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg

DRUGKetorolac

ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.

Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with renal and upper ureteral stones amenable to SWL.

Exclusion criteria

* Allergy to pethidine. * Allergy to Ketorolac. * Allergy to Xylocaine gel. * American Society of Anesthesiologists score ≥ 3 (ASA III or more). * Pregnancy. * Patients with a pacemaker. * Bleeding diatheses. * Uncontrolled urinary tract infection (UTI). * Severe obesity which prevent targeting of the stone. * Body Mass IndexBMI (40 or more) * Arterial aneurysm in the vicinity of the stone. * Anatomical obstruction distal to the stone.

Design outcomes

Primary

MeasureTime frame
Pain control __ Outcome Measure by pain assessment scales of The National Initiative on Pain Control™ (NIPC™)10 months

Secondary

MeasureTime frame
Effect of anxiety on success of SWL __ Outcome Measure by Generalized Anxiety Disorder 7-item 10 months
Effect of anxiety on success of SWL __ Outcome Measure by The Patient Health Questionnaire (PHQ-9)10 months
Compare stone free rate __ Outcome Measure by ultrasound and plain x-ray 1 week after session. If no residual stone, NCCT scan.1 year

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026