Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
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|ClinicalTrials.gov Identifier: NCT03032458|
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Analgesia Urolithiasis||Drug: Pethidine Drug: Ketorolac Drug: Xylocaine Gel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Active Comparator: Pethidine
Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
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
Other Name: Pethidine 50
Active Comparator: Ketorolac
Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
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.
Other Name: Ketolac
Active Comparator: Xylocaine Gel
Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
Drug: Xylocaine Gel
Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
Other Name: lidocaine 2%
- Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)" [ Time Frame: 10 months ]
- Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item " [ Time Frame: 10 months ]
- Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)" [ Time Frame: 10 months ]
- Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032458
|Urology and Nephrology Center|
|Mansourah, Aldakahlia, Egypt, 35516|
|Study Chair:||Hassan Abol-Enein, MD, Phd||Urology and Nephrology Center|