Renal ColicPhase 1NSAIvsNMNCT02156596
IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
A Phase 1 study testing IV NSAI, NM and IV Serum Saline in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial summary
The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic. Determine the need for systematic outpatient prescription of NSAI. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- IV NSAI, NM and IV Serum Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- Feb 2013to Feb 2018
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 16 years old
- Consenting to participate in the study
- Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
- VAS> 50% at consultation
Who cannot join
- Inability to assess pain VAS;
- Pregnant or lactating woman;
- Recognized renal disease (glomerular filtration rate <60ml/kg/1.73m2);
- Known hepatic insufficiency;
- Known or suspected allergy to NSAIDs, morphine
- Peptic ulcer known;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.
The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.
Determine the need for systematic outpatient prescription of NSAI.
Read the detailed description
Renal colic are a frequent cause of consultation in the emergency departement (ED).
They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.
But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.
the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.
In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.
- Conditions
- Renal Colic
- Being tested
- IV NSAI, NM, IV Serum Saline, Nebulised Serum Saline
- Keywords
- renal colic, nebulised morphine, Intravenous NSAID
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV NSAIDrug
Also called ketoprofen IV
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
NMDrug
Also called morphine
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
IV Serum SalineDrug
Also called serum saline
50 ml of SS is given by IV root over 30 minutes
Nebulised Serum SalineDrug
Also called serum saline
3 nebulisations of 5ml SS each are given over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intravenous NSAI | Active comparator | patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes. Receives: Drug: IV NSAI; Drug: Nebulised Serum Saline |
| Nebulised Morphine | Experimental | patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes. Receives: Drug: NM; Drug: IV Serum Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacity: VAS pain reduction
The effectiveness of treatment is defined by a decrease in the intensity of pain corresponding to a decrease of the VAS above 50% at 60 minutes compared to baseline.
Measured: 5, 15, 30, 45 and 60 minutes
Secondary outcomes (2)
feasibility of the study: number of patients accepting the adhesion to protocol
the feasibility is assessed by comparing the number of patients accepting the protocol to the total number of patients consulting for RC; and the number of patients that actually completed the protocol course (if above 50%, the protocol is considered feasable).
Measured: at base line and at 60 minutes
safety: side effects of treatment
the safety of treatment is evaluated by the occurence of side effects at any time of the protocol.
only major side effects (repeated vomiting, untolerated dizziness, conscience troubles, dyspnea and allergic reaction) are admitted to stop the protocol.
Measured: 5, 15, 30, 45 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionFeb 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156596
- Sponsor's protocol ID
- NSAI vs Morphine
- Acronym
- NSAIvsNM
- Status last verified
- Feb 2020
- First submitted
- 3 Jun 2014
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.
- ClinicalTrials.gov ID
- NCT02156596
- Acronym / sponsor ID
- NSAIvsNM / NSAI vs Morphine
- Conditions
- Renal Colic
- Keywords
- renal colic, nebulised morphine, Intravenous NSAID
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Jun 2014 (estimated)
- 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.
The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.
Determine the need for systematic outpatient prescription of NSAI.
Detailed description
Renal colic are a frequent cause of consultation in the emergency departement (ED).
They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.
But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.
the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.
In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous NSAI | Active comparator | Drug: IV NSAI, Drug: Nebulised Serum Salinepatients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes. |
| Nebulised Morphine | Experimental | Drug: NM, Drug: IV Serum Salinepatients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Over 16 years old
- Consenting to participate in the study
- Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
- VAS> 50% at consultation
Key exclusion criteria (6 listed)
- Inability to assess pain VAS;
- Pregnant or lactating woman;
- Recognized renal disease (glomerular filtration rate <60ml/kg/1.73m2);
- Known hepatic insufficiency;
- Known or suspected allergy to NSAIDs, morphine
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 |
|---|---|---|
| IV NSAIAlso: ketoprofen IV100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root | Drug | Intravenous NSAI |
| NMAlso: morphine3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation) | Drug | Nebulised Morphine |
| IV Serum SalineAlso: serum saline50 ml of SS is given by IV root over 30 minutes | Drug | Nebulised Morphine |
| Nebulised Serum SalineAlso: serum saline3 nebulisations of 5ml SS each are given over 30 minutes | Drug | Intravenous NSAI |
Primary outcome
efficacity: VAS pain reduction
Time frame: 5, 15, 30, 45 and 60 minutes
The effectiveness of treatment is defined by a decrease in the intensity of pain corresponding to a decrease of the VAS above 50% at 60 minutes compared to baseline.
2 secondary outcomes
feasibility of the study: number of patients accepting the adhesion to protocol
Time frame: at base line and at 60 minutes
safety: side effects of treatment
Time frame: 5, 15, 30, 45 and 60 minutes
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 11 Feb 2020.
- official department siteLink provided by the sponsor.
- 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.
Nouira Semir, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV NSAI, NM and IV Serum Saline in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
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 4 inclusion and 6 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 11 Feb 2020. 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 Tunisia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacity: VAS pain reduction (time frame: 5, 15, 30, 45 and 60 minutes). 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 11 Feb 2020.