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

Renal Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780556
• Other study ID #: ASU 5418
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: May 2018

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Lornoxicam and mepridine
compare the effect of each to control pain

Locations

Country	Name	City	State
Egypt	?Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain feeling	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
Primary	No need for more analgesics	Rescue analgesics administration	Registration of analgesic needed for 12h after the attack