Back to resultsLornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Primary Purpose
Renal Colic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lornoxicam and mepridine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring Renal pain, lornoxicam, pethidine, emergency room, ketamine
Eligibility Criteria
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
Sites / Locations
- ِAin Shams University hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lornixicam
Pethidine
Arm Description
Patients received lornoxicam 8 mg intravenous to control pain
Patients received pethidine 50mg intravenous to control pain
Outcomes
Primary Outcome Measures
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.
No need for more analgesics
Rescue analgesics administration
Secondary Outcome Measures
Full Information
NCT ID
NCT03780556
First Posted
December 11, 2018
Last Updated
December 19, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03780556
Brief Title
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Official Title
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Renal pain, lornoxicam, pethidine, emergency room, ketamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lornixicam
Arm Type
Active Comparator
Arm Description
Patients received lornoxicam 8 mg intravenous to control pain
Arm Title
Pethidine
Arm Type
Active Comparator
Arm Description
Patients received pethidine 50mg intravenous to control pain
Intervention Type
Drug
Intervention Name(s)
Lornoxicam and mepridine
Intervention Description
compare the effect of each to control pain
Primary Outcome Measure Information:
Title
Change in pain feeling
Description
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.
Time Frame
0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
Title
No need for more analgesics
Description
Rescue analgesics administration
Time Frame
Registration of analgesic needed for 12h after the attack
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
ِAin Shams University hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
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