- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937896
Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control
October 18, 2016 updated by: Kambiz Nasiri, Shahid Beheshti University of Medical Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- renal colic patients
Exclusion Criteria:
- history of hypertension and cardiac disease
- pregnant patients
- use of analgesic within 4 hours before intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ketorolac
30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline.
|
30mg intravenous Ketorolac.
Other Names:
1cc intravenous Normal Saline.
Other Names:
4 puffs nasal Normal Saline.
Other Names:
|
|
ACTIVE_COMPARATOR: Desmopressin
40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous
|
1cc intravenous Normal Saline.
Other Names:
4 puffs nasal Normal Saline.
Other Names:
40 micrograms Nasal Desmopressin.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain score
Time Frame: Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention
|
Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
April 1, 2016
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 18, 2016
First Posted (ESTIMATE)
October 19, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
October 19, 2016
Last Update Submitted That Met QC Criteria
October 18, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Infant, Newborn, Diseases
- Renal Colic
- Colic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Natriuretic Agents
- Hemostatics
- Coagulants
- Antidiuretic Agents
- Ketorolac
- Deamino Arginine Vasopressin
Other Study ID Numbers
- 688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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