A Phase 4 interventional study of Pethidine and Ketorolac in Analgesia and Urolithiasis, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-05-29.
Sponsored by Mansoura University · Phase 4, Interventional, and Treatment
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.
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.
278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.
This study's enrollment of 165 is above the median of 100 across 197 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
Drug: Pethidine
Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
Drug: Ketorolac
Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
Drug: Xylocaine Gel
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
Also known as: Pethidine 50
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.
Also known as: Ketolac
Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
Also known as: 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
Plan to share: Yes — meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)
No publications or documents are linked to this record.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Mansoura University