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

Primary Purpose

Analgesia, Urolithiasis

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Pethidine
Ketorolac
Xylocaine Gel
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Shock Wave Lithotripsy, Ketorolac, Xylocaine Gel, Pethidine

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pethidine

Ketorolac

Xylocaine Gel

Arm Description

Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)

Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)

Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)

Outcomes

Primary Outcome Measures

Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2017
Last Updated
May 24, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03032458
Brief Title
Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
Official Title
Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Urolithiasis
Keywords
Shock Wave Lithotripsy, Ketorolac, Xylocaine Gel, Pethidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pethidine
Arm Type
Active Comparator
Arm Description
Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
Arm Title
Xylocaine Gel
Arm Type
Active Comparator
Arm Description
Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
Intervention Type
Drug
Intervention Name(s)
Pethidine
Other Intervention Name(s)
Pethidine 50
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Ketolac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xylocaine Gel
Other Intervention Name(s)
lidocaine 2%
Intervention Description
Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
Primary Outcome Measure Information:
Title
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "
Time Frame
10 months
Title
Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"
Time Frame
10 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Abol-Enein, MD, Phd
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Study Chair
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansourah
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

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

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