Although the synergistic effects of opioids and other analgesic drugs such as Non Steroidal Anti Inflammatory Drugs have been es-tablished in relieving acute pain due to renal calculi, to date no studies have evaluated the concomitant administra-tion of opiates and other drugs with analgesic effects, such as serotonin re-uptake inhibitors. Considering the high prevalence of renal colic, the present study was carried out to compare the effect of concomitant prescription of morphine and a placebo with that of morphine and citalopram on the management of acute pain due to renal calculi.
The present double-blind randomized clinical trial was carried out from October 2012 to March 2013 in the Al-Zahra educational Hospital in Isfahan, Iran. A total of 90 patients with acute renal colic pain were randomly divided into two groups of 45 subjects each. The subjects in one group received morphine and placebo and other morphine and citalopram. The patients’ pain severity was determined by visual analogue scale (VAS) before and 20 minutes after administration of medications. In case of persistent pain the second or even third dose was adminis-tered and the pain severity was once again determined
The decrease in pain severity in the morphine and citalopram group will be significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020812072N1
Registration date:2014-03-19, 1392/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Mehrdad Esmailian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3482
Email address
m_esmailian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synergistic Effects of Citalopram and Morphine in the Renal Colic Pain Relief
Public title
Citalopram in the Renal Colic Pain Relief Management
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria : an age range of 18-55; a clinical diagnosis of acute colicky pain; pain severity of 7-10 based on visual analogue scale (VAS) and patients’ written consent to participate in the study
The exclusion criteria : pregnancy or suspected of being pregnant; contraindication in relation to taking morphine and citalopram based on drug catalog; a history of dependence on opioids or Selective serotonin re-uptake inhibitors; receiving an analgesic during a 6-hour period before presentation; peritonitis or peritoneal symptoms and signs; any disease preventing communication and patient’s decision to leave the study
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Univercity of Medical Siences
Street address
Isfahan Univercity of Medical Siences
City
Isfahan
Postal code
391237
Approval date
2012-10-24, 1391/08/03
Ethics committee reference number
391237
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
Renal Colic
Timepoint
every 20 min for 3 times
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
pain severity
Timepoint
every 20 min for 3 times
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
control group : check VAS before drug injection then the patients recieved 5mg Morphine and placebo. every 20min patients recheck for pain sevrity and if they have severe pain, they recive another dose of 5mg Morphine.
Category
Treatment - Drugs
2
Description
intervention group : check VAS before drug injection then the patients recieved 5mg Morphine and 20mg Citalopram. every 20min patients recheck for pain sevrity and if they have severe pain, they recive another dose of 5mg Morphine and 20mg Citalopram.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra General Hospital
Full name of responsible person
Kashefi Parviz MD
Street address
Soffeh Blvd, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Iraj Bijan MD
Street address
Isfahan Medical University
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian MD
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Isfahan Medical University
City
Isfahan
Postal code
Phone
+98 31 1629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian MD
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Isfahan Medical University
City
Isfahan
Postal code
Phone
+98 31 1629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistan Professor of Emergency Medicine
Other areas of specialty/work
Street address
Alzahra General Hospital, Soffeh Blvd, Isfahan, Iran
City
Isfshan
Postal code
Phone
+98 31 1629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)