Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic

December 19, 2018 updated by: Ayman Anis Metry, Ain Shams University
Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and Group P administered pethidine and VAS was recorded for both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. They were randomly assigned to one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients, who did not administer any analgesics at least within the last two hours. - -
  • Patients aged between 20-60 years.

Exclusion Criteria:

  • Patients with previous renal surgery
  • liver and renal failure
  • hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,
  • gastrointestinal bleeding and perforation,
  • hypertensive and history of cardiac diseases
  • pregnancy and lactation and
  • urine examination showing more than 5 leukocytes suggestive of pyuria.
  • patients with hyperthyroidism are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lornixicam
Patients received lornoxicam 8 mg intravenous to control pain
Drug: Lornoxicam and mepridine
compare the effect of each to control pain
Active Comparator: Pethidine
Patients received pethidine 50mg intravenous to control pain
Drug: Lornoxicam and mepridine
compare the effect of each to control pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain feeling
Time Frame: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
We assess this through Visual analogue scale score to assess pain due to renal colic, number 10 means maximum pain feeling and 0 means no pain at all.
0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
No need for more analgesics
Time Frame: Registration of analgesic needed for 12h after the attack
Rescue analgesics administration
Registration of analgesic needed for 12h after the attack

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU 5418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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