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Completed

NCT Number: NCT03780556

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

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.

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Key information

Conditions

Renal Colic Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ِAin Shams University hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lornoxicam and mepridine

Drug

compare the effect of each to control pain

Primary outcomes

  1. 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.

  2. No need for more analgesics

    Time frame: Registration of analgesic needed for 12h after the attack

    Rescue analgesics administration

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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