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

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ClinicalTrials.gov Identifier: NCT03780556
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE January 2, 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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.
  • No need for more analgesics [ Time Frame: Registration of analgesic needed for 12h after the attack ]
    Rescue analgesics administration
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Change in pain score [ Time Frame: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups ]
    VAS score to assess pain due to renal colic
  • No need for more analgesics [ Time Frame: Registration of analgesic needed for 12h after the attack ]
    Rescue analgesics administration
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Official Title  ICMJE Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Renal Colic
Intervention  ICMJE Drug: Lornoxicam and mepridine
compare the effect of each to control pain
Study Arms  ICMJE
  • Active Comparator: Lornixicam
    Patients received lornoxicam 8 mg intravenous to control pain
    Intervention: Drug: Lornoxicam and mepridine
  • Active Comparator: Pethidine
    Patients received pethidine 50mg intravenous to control pain
    Intervention: Drug: Lornoxicam and mepridine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2018)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03780556
Other Study ID Numbers  ICMJE ASU 5418
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Anis Metry, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP