Renal ColicNCT03780556
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
A study testing Lornoxicam and mepridine in people with Renal Colic, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic
- What is being tested?
- Lornoxicam and mepridine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients, who did not administer any analgesics at least within the last two hours. - -
- Patients aged between 20-60 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Renal Colic
- Being tested
- Lornoxicam and mepridine
- Keywords
- Renal pain, lornoxicam, pethidine, emergency room, ketamine
- Medical subject headings
- Renal Colic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lornoxicam and mepridineDrug
compare the effect of each to control pain
| Study group | Role | What they receive |
|---|---|---|
| Lornixicam | Active comparator | Patients received lornoxicam 8 mg intravenous to control pain Receives: Drug: Lornoxicam and mepridine |
| Pethidine | Active comparator | Patients received pethidine 50mg intravenous to control pain Receives: Drug: Lornoxicam and mepridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
No need for more analgesics
Rescue analgesics administration
Measured: Registration of analgesic needed for 12h after the attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start2 Jan 2016
- Primary completionJul 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780556
- Sponsor's protocol ID
- ASU 5418
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
- ClinicalTrials.gov ID
- NCT03780556
- Acronym / sponsor ID
- ASU 5418
- Conditions
- Renal Colic
- Keywords
- Renal pain, lornoxicam, pethidine, emergency room, ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lornixicam | Active comparator | Drug: Lornoxicam and mepridinePatients received lornoxicam 8 mg intravenous to control pain |
| Pethidine | Active comparator | Drug: Lornoxicam and mepridinePatients received pethidine 50mg intravenous to control pain |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients, who did not administer any analgesics at least within the last two hours. - -
- Patients aged between 20-60 years.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lornoxicam and mepridinecompare the effect of each to control pain | Drug | Lornixicam, Pethidine |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lornoxicam and mepridine in people with Renal Colic, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain feeling (time frame: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.