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

NCT03032458 | Completed Phase 4 DMC

• 1 other identifier: MD/16.11.72
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia; Urolithiasis

Keywords

Shock Wave Lithotripsy; Ketorolac; Xylocaine Gel; Pethidine

Outcome Measures

Primary Outcomes (1)

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

  10 months

Secondary Outcomes (3)

• 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

Study Arms (3)

Pethidine

ACTIVE COMPARATOR

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

Drug: Pethidine

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Xylocaine Gel

ACTIVE COMPARATOR

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

Drug: Xylocaine Gel

Interventions

Pethidine DRUG

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

Pethidine

Ketorolac DRUG

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

Ketorolac

Xylocaine Gel DRUG

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%

Xylocaine Gel

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Agnosia; Urolithiasis

Interventions

Meperidine; Ketorolac

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hassan Abol-Enein, MD, Phd

  Urology and Nephrology Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)