The comparison of analgesic effect of haloperidol plus morphin with morphin alone in patients with acute renal colic presenting to emergency department
objectives: to comparison of analgesic effect of haloperidol plus morphine sulfate in contrast to morphine sulfate alone in renal colic
design setting and conduct: in this clinical trial that is a phase 2 and 3 study and done on two groups case and control with 70 patients in each one, we give morphine and haloperidol to case group and morphine alone to control group and then comparise these two with each other at minute 60, at last each patient with pain score 5 or upper will get intravenous fentanyl
inclusion criteria: clinical and para-clinical findings suggestive of renal colic in 18-55 years old patients
exclusion criteria: decreased level of consciousness; pregnancy; heart disease; renal disease; allergy to morphine or haloperidol; severe side effects like nausea and vomiting
main outcome measures: patient's pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224136N1
Registration date:2015-11-22, 1394/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Ali Delirrooyfard
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 612229155
Email address
delirrooyfard-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice challencor for reasearch of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-08-02, 1394/05/11
Expected recruitment end date
2016-02-02, 1394/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of analgesic effect of haloperidol plus morphin with morphin alone in patients with acute renal colic presenting to emergency department
Public title
The comparison of analgesic effect of haloperidol plus morphin with morphin alone in patients with acute renal colic presenting to emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: clinical and para-clinical evidence of renal colic in 18-55 years old patients with flank pain
exclusion criteria: decreased level of consciousness; age below 18 or above 55 years old; renal disease; heart disease; pregnancy; allergy to haloperidol or morphine; severe side effects like nausea and vomiting
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of closed envelopes that randomely puts the patient in one of intervention or control groups will be used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
IR.AJUMS.REC.1394.173
Health conditions studied
1
Description of health condition studied
Urilothiasis
ICD-10 code
N23
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Visual analoge scale for pain
Timepoint
Before intervention, 20 minutes after intervention, 40 minutes after intervention, 60 minutes after intervention
Method of measurement
millimeter
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
Before Intervention, 20 Minutes after intervention, 40 minutes after intervention, 60 minutes after intervention
Method of measurement
Questionnaire
2
Description
Extrapyramidal side effects
Timepoint
Before Intervention, 20 Minutes after intervention, 40 minutes after intervention, 60 minutes after intervention