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

Not Applicable

Completed

• Conditions: Renal Colic
• Interventions: Drug: Lornoxicam and mepridine

• Registration Number: NCT03780556
• Lead Sponsor: Ain Shams University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01-02
• Primary Completion: 2017-07
• Study Completion: 2018-05
• Status Verified: 2018-12
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lornixicam	Lornoxicam and mepridine	Patients received lornoxicam 8 mg intravenous to control pain
Pethidine	Lornoxicam and mepridine	Patients received pethidine 50mg intravenous to control pain

Primary Outcome Measures

Name	Time	Method
No need for more analgesics	Registration of analgesic needed for 12h after the attack	Rescue analgesics administration
Change in pain feeling	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.

Trial Locations

Locations (1)

ِAin Shams University hospitals; 🇪🇬 Cairo, Egypt