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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032458
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date May 29, 2018
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)" [ Time Frame: 10 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
Official Title  ICMJE Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Analgesia
  • Urolithiasis
Intervention  ICMJE
  • Drug: Pethidine
    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
  • Drug: Ketorolac
    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
  • 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%
Study Arms  ICMJE
  • Active Comparator: Pethidine
    Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
    Intervention: Drug: Pethidine
  • Active Comparator: Ketorolac
    Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
    Intervention: Drug: Ketorolac
  • Active Comparator: Xylocaine Gel
    Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
    Intervention: Drug: Xylocaine Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
165
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032458
Other Study ID Numbers  ICMJE MD/16.11.72
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)
Responsible Party Abdelwahab Hashem, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hassan Abol-Enein, MD, Phd Urology and Nephrology Center
PRS Account Mansoura University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP