Renal ColicNCT02937896
Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control
A study testing Desmopressin, Ketorolac and Normal Saline in people with Renal Colic, run by Shahid Beheshti University of Medical Sciences.
Trial summary
The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Desmopressin, Ketorolac and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2016
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- renal colic patients
Who cannot join
- history of hypertension and cardiac disease
- pregnant patients
- use of analgesic within 4 hours before intervention
About this study
Official title: Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients
The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.
Read the detailed description
40 renal colic patients have been divided into 2 groups randomly, one group has been received 30mg intravenous Ketorolac and 4 puffs nasal Normal Saline while other has been received 40 micrograms nasal Desmopressin and 1cc intravenous Normal Saline. Pain Score before drug administration,also 10, 30 and 60 minutes after drug administration has been measured bye Visual Analogue Scale ( VAS ).
- Conditions
- Renal Colic
- Being tested
- Desmopressin, Ketorolac, Normal Saline
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Ddavp
40 micrograms Nasal Desmopressin.
KetorolacDrug
Also called Toradol
30mg intravenous Ketorolac.
Normal SalineDrug
Also called NaCl
1cc intravenous Normal Saline.
Normal SalineDrug
Also called NaCl
4 puffs nasal Normal Saline.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | 30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline. Receives: Drug: Ketorolac; Drug: Normal Saline |
| Desmopressin | Active comparator | 40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous Receives: Drug: Desmopressin; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionApr 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kambiz Nasiri, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937896
- Sponsor's protocol ID
- 688
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients
- ClinicalTrials.gov ID
- NCT02937896
- Acronym / sponsor ID
- 688
- Conditions
- Renal Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Oct 2016 (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 this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.
Detailed description
40 renal colic patients have been divided into 2 groups randomly, one group has been received 30mg intravenous Ketorolac and 4 puffs nasal Normal Saline while other has been received 40 micrograms nasal Desmopressin and 1cc intravenous Normal Saline. Pain Score before drug administration,also 10, 30 and 60 minutes after drug administration has been measured bye Visual Analogue Scale ( VAS ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: Ketorolac, Drug: Normal Saline30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline. |
| Desmopressin | Active comparator | Drug: Desmopressin, Drug: Normal Saline40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- renal colic patients
Key exclusion criteria (3 listed)
- history of hypertension and cardiac disease
- pregnant patients
- use of analgesic within 4 hours before intervention
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 |
|---|---|---|
| DesmopressinAlso: Ddavp40 micrograms Nasal Desmopressin. | Drug | Desmopressin |
| KetorolacAlso: Toradol30mg intravenous Ketorolac. | Drug | Ketorolac |
| Normal SalineAlso: NaCl1cc intravenous Normal Saline. | Drug | Desmopressin |
| Normal SalineAlso: NaCl4 puffs nasal Normal Saline. | Drug | Ketorolac |
Primary outcome
Pain score
Time frame: Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention
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 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopressin, Ketorolac and Normal Saline in people with Renal Colic, run by Shahid Beheshti University of Medical Sciences.
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 1 inclusion and 3 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain score (time frame: Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention). 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 19 Oct 2016.