Renal ColicPhase 4NCT02187614
Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management
A Phase 4 study testing Diclofenac, Morphine and Paracetamol in people with Renal Colic and Urinary Calculi, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Colic, Urinary Calculi
- What is being tested?
- Diclofenac, Morphine and Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,645 participants
- Where
- 1 siteQatar
- Study dates
- Aug 2014to Mar 2015
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years and < 65 years
- Acute onset, one side flank or loin pain, with or without radiation to groin or genital areas.
- Pain intensity on NRS more than or equal to 4. (Moderate to Severe Pain)
- Diagnosis confirmed by non contrast CT KUB within the ED visit.
Who cannot join
- Traumatic flank pain
- Pregnancy
- Known renal failure or impairment
- Known allergy to morphine, diclofenac or paracetamol
- Bronchial asthma
- Previously enrolled in the study.
- Use of any analgesia in last 6 hour.
Trial locations and contacts
1 site in 1 country.
Qatar1 site
Emergency Department, Hamad General Hospital.
Doha, Baladiyat ad Dawhah, 3050
About this study
Official title: A Double Blind, Multi-arm Randomized Control Trial, for Efficacy of Intramuscular Diclofenac Versus Intravenous Morphine Versus Intravenous Paracetamol, in Renal Colic Emergency Department Pain Management
Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and to be pain free as early as possible. There are variations in physician preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:
- Opioids such as Morphine or Fentanyl
- Non steroidal drugs such as Diclofenac, Ketorolac or Brufen
- and Paracetamol intravenous injection.
A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking. This study is design to obtain data on efficacy of these three drugs within 30 minutes in a non inferiority trail.
Read the detailed description
This will be a double blind RCT, where participants will be enrolled consecutively after meeting eligibility criteria and obtaining a written informed consent. They will be assign to one of the three study arms by computer generated randomization process. The study packets will be prepared by a dedicated nurse or pharmacist who will not a part of investigating team. Each Patients will receive one analgesic drug (active drug) and two placebos. Drugs will be given as one intramuscular injection and two intravenous solutions.
Pain score will be recorded using NRS at 0, 30, 60, and 90 minutes. Data will be collected on standard Data collection form. Each participant will receive analgesia from study packet which contains, one active drug and two placebos to be administer as one intramuscular and two intravenous solutions. At any given time every patient will receive one analgesia from either Diclofenac, Paracetamol or Morphine. If patient pain does not respond to initial treatments, at 30 minutes a rescue analgesia in form of morphine will be administered till patient is pain free or NRS<=2 or adverse event to morphine.
Based on the results of previous studies (1-3), proportion of patients achieving more than 50% pain reduction, is between 65-75% for diclofenac, morphine and paracetamol when compared with other drugs. In each group, 437 patients are required to detect a difference of 10% in primary outcome, in a superiority trial with power (1-beta) of 90% and significance level (alpha) of 5% in this study. Considering 15% extra, total sample size required in this superiority trial will be 1507 patients in total.
Data will be collected on a standard data recording form and it will be converted to electronic excel sheet hiding patient identifiable details. Continuous variables will be presented as mean with standard deviation (SD). Categorical variables will be calculated as proportions and presented with 95% Confidence interval (CI). Statistical analyses will be undertaken using Stata 12.0 (College Station, Texas).
- Conditions
- Renal Colic, Urinary Calculi
- Being tested
- Diclofenac, Morphine, Paracetamol, Placebos
- Keywords
- Acute Renal colic, Acute Ureteric Colic, Renal or Ureteral Calculi, Urolithiasis, Kidney or Ureteral stones
- Medical subject headings
- Renal Colic, Urinary Calculi, Ureteral Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Also called Voltaren, Diclofen, Diclorex
MorphineDrug
Also called Morphine sulphate
ParacetamolDrug
Also called Perfalgan, Acetaminophen
PlacebosDrug
Also called saline solution
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac and Placebos | Experimental | Participants in this group will receive a Diclofenac 75 mg intramuscular injection, and two placebo saline solutions intravenously. Receives: Drug: Diclofenac; Drug: Placebos |
| Morphine and Placebos | Active comparator | Participants in this group will receive Morphine 0.1 mg/kg intravenously, along with an additional intravenous placebo and an intramuscular placebo injection. Receives: Drug: Morphine; Drug: Placebos |
| Paracetamol and Placebos | Active comparator | participants in this group will receive intravenous Paracetamol 1 gm solution, along with an additional intravenous placebo and an intramuscular placebo injection. Receives: Drug: Paracetamol; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm.
Measured: at 30 minutes after analgesia
Secondary outcomes (1)
reduction in mean NRS
Measured: at 30, 60 and 90 minutes after analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. SAMEER PATHAN, Hamad Medical Corporation
- Investigators
- Dr.Sameer A. Pathan, MBBS, MCEM, Principal investigator, Hamad Medical CorporationProf. Peter A Cameron, MD,FACEM, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187614
- Sponsor's protocol ID
- IRB Number: 14-00059
- Other IDs
- Hamad Medical Corporation-MRC
- Status last verified
- Mar 2015
- First submitted
- 7 Jul 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Grissa MH, Claessens YE, Bouida W, Boubaker H, Boudhib L, Kerkeni W, Boukef R, Nouira S. Paracetamol vs piroxicam to relieve pain in renal colic. Results of a randomized controlled trial. Am J Emerg Med. 2011 Feb;29(2):203-6. doi: 10.1016/j.ajem.2009.09.019. Epub 2010 Oct 8.
PubMed 20934829Behzadnia MJ, Javadzadeh HR, Saboori F. Time of admission, gender and age: challenging factors in emergency renal colic - a preliminary study. Trauma Mon. 2012 Fall;17(3):329-32. doi: 10.5812/traumamon.6800. Epub 2012 Oct 10.
PubMed 24350118Shaden Salameh; Nurit Hiller; Meir Antopolsky; Fedaa Ghanem; Yigaal Abramovitz; Ruth Stalnikowics. Diclofenac versus Tramadol in the Treatment of Renal Colic: A Prospective, Randomized Trial. The Open Emergency Medicine Journal. 2011; 4: 9-13.
Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
PubMed 26993881
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Multi-arm Randomized Control Trial, for Efficacy of Intramuscular Diclofenac Versus Intravenous Morphine Versus Intravenous Paracetamol, in Renal Colic Emergency Department Pain Management
- ClinicalTrials.gov ID
- NCT02187614
- Acronym / sponsor ID
- IRB Number: 14-00059
- Conditions
- Renal Colic, Urinary Calculi
- Keywords
- Acute Renal colic, Acute Ureteric Colic, Renal or Ureteral Calculi, Urolithiasis, Kidney or Ureteral stones
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,645 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Jul 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.
Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and to be pain free as early as possible. There are variations in physician preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:
- Opioids such as Morphine or Fentanyl
- Non steroidal drugs such as Diclofenac, Ketorolac or Brufen
- and Paracetamol intravenous injection.
A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking. This study is design to obtain data on efficacy of these three drugs within 30 minutes in a non inferiority trail.
Detailed description
This will be a double blind RCT, where participants will be enrolled consecutively after meeting eligibility criteria and obtaining a written informed consent. They will be assign to one of the three study arms by computer generated randomization process. The study packets will be prepared by a dedicated nurse or pharmacist who will not a part of investigating team. Each Patients will receive one analgesic drug (active drug) and two placebos. Drugs will be given as one intramuscular injection and two intravenous solutions.
Pain score will be recorded using NRS at 0, 30, 60, and 90 minutes. Data will be collected on standard Data collection form. Each participant will receive analgesia from study packet which contains, one active drug and two placebos to be administer as one intramuscular and two intravenous solutions. At any given time every patient will receive one analgesia from either Diclofenac, Paracetamol or Morphine. If patient pain does not respond to initial treatments, at 30 minutes a rescue analgesia in form of morphine will be administered till patient is pain free or NRS<=2 or adverse event to morphine.
Based on the results of previous studies (1-3), proportion of patients achieving more than 50% pain reduction, is between 65-75% for diclofenac, morphine and paracetamol when compared with other drugs. In each group, 437 patients are required to detect a difference of 10% in primary outcome, in a superiority trial with power (1-beta) of 90% and significance level (alpha) of 5% in this study. Considering 15% extra, total sample size required in this superiority trial will be 1507 patients in total.
Data will be collected on a standard data recording form and it will be converted to electronic excel sheet hiding patient identifiable details. Continuous variables will be presented as mean with standard deviation (SD). Categorical variables will be calculated as proportions and presented with 95% Confidence interval (CI). Statistical analyses will be undertaken using Stata 12.0 (College Station, Texas).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac and Placebos | Experimental | Drug: Diclofenac, Drug: PlacebosParticipants in this group will receive a Diclofenac 75 mg intramuscular injection, and two placebo saline solutions intravenously. |
| Morphine and Placebos | Active comparator | Drug: Morphine, Drug: PlacebosParticipants in this group will receive Morphine 0.1 mg/kg intravenously, along with an additional intravenous placebo and an intramuscular placebo injection. |
| Paracetamol and Placebos | Active comparator | Drug: Paracetamol, Drug: Placebosparticipants in this group will receive intravenous Paracetamol 1 gm solution, along with an additional intravenous placebo and an intramuscular placebo injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18 years and < 65 years
- Acute onset, one side flank or loin pain, with or without radiation to groin or genital areas.
- Pain intensity on NRS more than or equal to 4. (Moderate to Severe Pain)
- Diagnosis confirmed by non contrast CT KUB within the ED visit.
Key exclusion criteria (7 listed)
- Traumatic flank pain
- Pregnancy
- Known renal failure or impairment
- Known allergy to morphine, diclofenac or paracetamol
- Bronchial asthma
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 |
|---|---|---|
| DiclofenacAlso: Voltaren, Diclofen, Diclorex | Drug | Diclofenac and Placebos |
| MorphineAlso: Morphine sulphate | Drug | Morphine and Placebos |
| ParacetamolAlso: Perfalgan, Acetaminophen | Drug | Paracetamol and Placebos |
| PlacebosAlso: saline solution | Drug | Diclofenac and Placebos, Morphine and Placebos, Paracetamol and Placebos |
Primary outcome
The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm.
Time frame: at 30 minutes after analgesia
1 secondary outcome
reduction in mean NRS
Time frame: at 30, 60 and 90 minutes after analgesia
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 18 Mar 2015.
- Background: PubMed 20934829Grissa MH, Claessens YE, Bouida W, Boubaker H, Boudhib L, Kerkeni W, Boukef R, Nouira S. Paracetamol vs piroxicam to relieve pain in renal colic. Results of a randomized controlled trial. Am J Emerg Med. 2011 Feb;29(2):203-6. doi: 10.1016/j.ajem.2009.09.019. Epub 2010 Oct 8.
- Background: PubMed 24350118Behzadnia MJ, Javadzadeh HR, Saboori F. Time of admission, gender and age: challenging factors in emergency renal colic - a preliminary study. Trauma Mon. 2012 Fall;17(3):329-32. doi: 10.5812/traumamon.6800. Epub 2012 Oct 10.
- BackgroundShaden Salameh; Nurit Hiller; Meir Antopolsky; Fedaa Ghanem; Yigaal Abramovitz; Ruth Stalnikowics. Diclofenac versus Tramadol in the Treatment of Renal Colic: A Prospective, Randomized Trial. The Open Emergency Medicine Journal. 2011; 4: 9-13.
- Derived from this study: PubMed 26993881Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
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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.
Dr.Sameer A. Pathan, MBBS, MCEM principal investigator
Hamad Medical Corporation
Prof. Peter A Cameron, MD,FACEM principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac, Morphine and Paracetamol in people with Renal Colic and Urinary Calculi, run by Hamad Medical Corporation at 1 site in Qatar.
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 7 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 18 Mar 2015. 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 Qatar. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm. (time frame: at 30 minutes after analgesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02187614, which also lists 4 linked publications.
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 18 Mar 2015.