Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management
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
2 other identifiers
interventional
1,645
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 18, 2015
March 1, 2015
6 months
July 7, 2014
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at 30 minutes after analgesia
Secondary Outcomes (1)
reduction in mean NRS
at 30, 60 and 90 minutes after analgesia
Other Outcomes (2)
adverse event rate
Within 14 days of ED visit
total analgesia requirement to get pain score (NRS) less than or equal to 2.
by 90 minutes
Study Arms (3)
Diclofenac and Placebos
EXPERIMENTALParticipants in this group will receive a Diclofenac 75 mg intramuscular injection, and two placebo saline solutions intravenously.
Morphine and Placebos
ACTIVE COMPARATORParticipants 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 COMPARATORparticipants in this group will receive intravenous Paracetamol 1 gm solution, along with an additional intravenous placebo and an intramuscular placebo injection.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emergency Department, Hamad General Hospital.
Doha, Baladīyat ad Dawḩah, 3050, Qatar
Related Publications (4)
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.
PMID: 20934829BACKGROUNDBehzadnia 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.
PMID: 24350118BACKGROUNDShaden 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.
BACKGROUNDPathan 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.
PMID: 26993881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr.Sameer A. Pathan, MBBS, MCEM
Hamad Medical Corporation
- PRINCIPAL INVESTIGATOR
Prof. Peter A Cameron, MD,FACEM
Hamad Medical Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow and Specialist
Study Record Dates
First Submitted
July 7, 2014
First Posted
July 11, 2014
Study Start
August 1, 2014
Primary Completion
February 1, 2015
Study Completion
March 1, 2015
Last Updated
March 18, 2015
Record last verified: 2015-03