NCT03780556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

December 11, 2018

Last Update Submit

December 19, 2018

Conditions

Renal Colic

Keywords

Renal painlornoxicampethidineemergency roomketamine

Outcome Measures

Primary Outcomes (2)

  • 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

  • No need for more analgesics

    Rescue analgesics administration

    Registration of analgesic needed for 12h after the attack

Study Arms (2)

Lornixicam

ACTIVE COMPARATOR

Patients received lornoxicam 8 mg intravenous to control pain

Drug: Lornoxicam and mepridine

Pethidine

ACTIVE COMPARATOR

Patients received pethidine 50mg intravenous to control pain

Drug: Lornoxicam and mepridine

Interventions

Lornoxicam and mepridineDRUG

compare the effect of each to control pain

LornixicamPethidine

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients, who did not administer any analgesics at least within the last two hours. - -
  • Patients aged between 20-60 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ِAin Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Renal ColicEmergencies

Interventions

lornoxicam

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 19, 2018

Study Start

January 2, 2016

Primary Completion

July 1, 2017

Study Completion

May 1, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)