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

NCT ID: NCT03780556

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-02

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Renal Colic

Keywords

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Renal pain lornoxicam pethidine emergency room ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lornixicam

Patients received lornoxicam 8 mg intravenous to control pain

Group Type ACTIVE_COMPARATOR

Lornoxicam and mepridine

Intervention Type DRUG

compare the effect of each to control pain

Pethidine

Patients received pethidine 50mg intravenous to control pain

Group Type ACTIVE_COMPARATOR

Lornoxicam and mepridine

Intervention Type DRUG

compare the effect of each to control pain

Interventions

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Lornoxicam and mepridine

compare the effect of each to control pain

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ِAin Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASU 5418

Identifier Type: -

Identifier Source: org_study_id