Comparison of analgesic effects of Morphine and Indomethacin suppositories in patients with clinical diagnosis of renal colic referred to emergency wards of Shariati and Imam Khomeini hospitals
(1) Objectives: Comparison of analgesic effects of Morphine and Indomethacin suppositories in patients with clinical diagnosis of renal colic referred to emergency wards of Shariati and Imam Khomeini hospitals; (2) Design: The study is a randomized, multicenter, double-blinded clinical trial which is conducted on adult patients; (3) Setting and methods: Patients with clinical diagnosis of renal colic referred to Shariati and Imam Khomeini hospitals are randomly divided into two groups. One of the groups is treated with 100 mg indomethacin suppository and the other group with 10 mg morphine suppository; (4) Participants including major eligibility criteria: The main inclusion criteria: Patients between 18-85 years old referred to emergency ward with clinical diagnosis of renal colic initially diagnosed by triage nurses and confirmed by emergency medicine residents; The main Exclusion criteria: Substance abuse; Taking analgesics 4 hours before referral; Past history of drug reaction to morphine or NSAIDs; Refuse to take rectal analgesic drug; (5) Interventions: One of the intervention groups is treated with 100 mg indomethacin suppository and other group with 10 mg morphine suppository; (6) Main outcome measures: Pain severity is assessed at the emergency entrance and after 20, 40, 60 and 90 minutes using Visual Analogue Scale (VAS). Concomitant symptoms, any drug side effects (nausea and vomiting, drowsiness, allergy) or any changes in vital signs are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050514297N2
Registration date:2014-06-01, 1393/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-01, 1393/03/11
Registrant information
Name
Seyed Mojtaba Aghili
Name of organization / entity
Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 4848
Email address
m-aghili@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of Morphine and Indomethacin suppositories in patients with clinical diagnosis of renal colic referred to emergency wards of Shariati and Imam Khomeini hospitals
Public title
Comparison of analgesic effects of Morphine and Indomethacin suppositories in patients with clinical diagnosis of renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18-85 years old with clinical diagnosis of renal colic referred to emergency ward; Consent to participate in the trial
Exclusion criteria: Patient's refusal for entering the study; Pregnancy; Substance abuse; Taking analgesics 4 hours before referral; Past history of drug reaction to morphine or NSAIDs; Refuse to take rectal analgesic drug; Diarreha; Past history of chronic liver or kidney disease, COPD, Hypercapnea, Mild or severasthma, Sleep apnea syndorme, History of ileus, paralytic, Hypotension, IBD, Chronic Pancreatitis, Chronic bile duct dysfunction, Confusion, Severe anemia,Hipnotic drugs and phenothiazine, Adrenocortical dysfunction, Untreated hypothyroidism, Hypovolemia; Breast feeding; Chronic consumption of NSAIDs; Peritonitis
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization for University, Ghods St., Keshavarz's Blvd
City
Tehran
Postal code
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
2995/130/د/92
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
The analgesic effect of drugs
Timepoint
Immediately before, 20, 40, 60 and 90 minutes after drugs administration
Method of measurement
Pain scores (VAS)
Secondary outcomes
1
Description
Vital sign changes
Timepoint
Immediately before, 20, 40 and 60 minutes after administration of drugs
Method of measurement
Clinical examination
2
Description
Nausea and vomiting
Timepoint
Immediately before, 20, 40 and 60 minutes after administration of drugs
Method of measurement
Questionnaire
3
Description
Drowsiness
Timepoint
Immediately before, 20, 40 and 60 minutes after administration of drugs
Method of measurement
Questionnaire
4
Description
Dry mouth
Timepoint
Immediately before, 20, 40 and 60 minutes after administration of drugs
Method of measurement
Questionnaire
5
Description
Allergy
Timepoint
Immediately before, 20, 40 and 60 minutes after administration of drugs
Method of measurement
Clinical examination and Questionnaire
Intervention groups
1
Description
In the first intervention group, 100 mg Indomethacin suppository (the standard treatment for renal colic) is administered.
Category
Treatment - Drugs
2
Description
In the other group 10 mg morphine suppository is administered
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati and Imam Khomeini Hospitals
Full name of responsible person
Seyed Mojtaba Aghili
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Sixth Floor, Central Organization for University, Ghods St., Keshavarz's Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Imam Khomeini Hospital
Full name of responsible person
Forough Zamanian
Position
Emergency Medicine Assistant
Other areas of specialty/work
Street address
Keshavarz Blvd, Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
dr.foroughzamanian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Seyed Mojtaba Aghili
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
+98 21 6690 4848
Email
m-aghili@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Forough Zamanian
Position
Emergency Medicine Assistant
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
dr.foroughzamanian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)