The purpose of this study is to assess the analgesic efficacy of Dexmedetomidine (IV) comparing with Ketorolac (IV) on patients with renal colic diagnosis in the intensity of pain using a visual pain analogue scale (VPAS), a four-grade (five points) pain intensity (PI) scale and a pain-relief scale. 160 patients with confirmed renal colic and Pain score < 3 will be selected. In this active-controlled, double-centre, randomized, single-blind study, the patients will be blinded about Receiving Drug and Active allocation. Patients will be randomized into two groups; Dexmedetomidine group and Ketorolac group. The primary endpoint is the evaluation of the sedative effect of Dexmedetomidine during a 1-h study period, to confirm that Dexmedetomidine abolished or significantly decreased the intensity of pain in renal colic in comparison with Ketorolac. The painkilling effect was defined as a decrease by at least half in the PI scale, and/or a ≥40% decrease in the VAS 20, 40, and 60 min after the first injection of Dexmedetomidine or Ketorolac.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120625402N1
Registration date:2015-12-17, 1394/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Ali Delirrooyfard
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
mosaffa.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of Dexmedetomidine efficacy on acute renal colic in comparison with Ketorolac presenting to the emergency department
Public title
The Effect of Dexmedetomidine on renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: typical physical complaints; a pain intensity between 3 to 10 on a 10 cm visual analogue scale (VAS) marked by the patient; a ureteric or kidney stone verified by ultrasonography and/or native abdominal X-ray; informed consent by the patient; and in women of fertile age, the apparent use of efficient contraception
Exclusion criteria: Age<18 y/o and age > 55y/o; Pain score < 3; Pian killer during 6 hours befor ED arrival; Addiction; Sensitivity to opioides or NSAIDs; Sensitivity to opioides or NSAIDs; SBP<90 mmHg; Abdominal tenderness and rebound; Body temperature>38 °C; History or documents suggesting cardiac, liver, respiratory or renal diseases; History of GIB or active GI ulcer; History of seizure; History of metabolic Disorder; Pregnancy; Suspicious abdominal aortic aneurism or dissection; Inability to speech
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Ahvaz Jundishapur University of Medical Sciences
Street address
I.R.Iran - Awz, Mailbox: 159
City
Ahvaz
Postal code
6135715794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.ajums.rec.1394.430
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Duration and intensity of pain in renal colic
Timepoint
Baseline
Method of measurement
visual analogue pain scale (VPAS)
Secondary outcomes
1
Description
Decrease in duration and intensity of pain in renal colic
Timepoint
20, 40, and 60 min after the first injection
Method of measurement
visual analogue pain scale (VPAS)
Intervention groups
1
Description
Intervention Group: Receiving intravenous Dexmedetomidine (200mcg/ml vials) with a dose of 1 gram in 100 ml normal saline during 10 minutes (a 1-h study period, Time Frame: 20 minutes interval) and measuring the pain intensity (PI) in the VAS and adverse events
Category
Treatment - Drugs
2
Description
Control Group: Receiving intravenous Ketorolac (30 mg /ml vials) with a dose of 1 gram in 100 ml normal saline during 10 minutes (a 1-h study period, Time Frame: 20 minutes interval) and measuring the pain intensity (PI) in the VAS and adverse events