Protocol summary

Summary
This interventional study (before-after) was conducted on 70 patients who were candidates for appendicitis surgery and referred to Shahid Sadoughi and Farokhi hospitals, Yazd, Iran. The patients were selected in a non random manner. No placebo group was considered since there was no expectation to reduce the pain without analgesics. Inclusion criteria of the current study were as follows: taking any psychiatric medicine, lesions on the abdominal surface such as cellulite, scars, taking analgesic drugs before entering the emergency room, hiatal hernia, history of kidney stones, current urinary infection, history of trauma on the area during last 2 weeks, menstrual bleeding, drug addiction. Sensitivity to drug was considered as exclusion criterion. First demographic information such as age and sex was obtained. To establish appendicitis diagnosis of surgery candidates, patients’ rebound tenderness and pain were evaluated using numeric rating scale. Then 0.3 mg /kg of hyoscine was administered intravenously. Using the previous method, rebound tenderness and pain were remeasured fifteen minutes later. Regarding the possibility of negative appendectomy or other diagnoses, 70 patients diagnosed with appendicitis by pathologist were underwent further investigation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111825123N1
Registration date: 2016-12-08, 1395/09/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
vahide salimi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 913 354 9734
Email address
vahidesalimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi university of medical sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hyoscine on severity of pain, tenderness and rebound tenderness in patients candidate for appendectomy
Public title
Effect of hyoscine on severity of pain, tenderness and rebound tenderness in patients candidate for appendectomy
Purpose
Supportive
Inclusion/Exclusion criteria
exclusion criteria: other medical problems; psychological problems; painful lesion; analgesic using; umbilicall hernia; History of kidney stones; UTI; addiction; trauma during past 2 weeks; reaction to drug inclusion criteria:15-45 year olds; candidate for appendectomy
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This interventional study (before-after) was conducted on 70 patients who were candidates for appendicitis surgery and referred to Shahid Sadoughi and Farokhi hospitals, Yazd, Iran. The patients were selected in a non random manner. No placebo group was considered since there was no expectation to reduce the pain without analgesics. Inclusion criteria of the current study were as follows: taking any psychiatric medicine, lesions on the abdominal surface such as cellulite, scars, taking analgesic drugs before entering the emergency room, hiatal hernia, history of kidney stones, current urinary infection, history of trauma on the area during last 2 weeks, menstrual bleeding, drug addiction. Sensitivity to drug was considered as exclusion criterion. First demographic information such as age and sex was obtained. To establish appendicitis diagnosis of surgery candidates, patients’ rebound tenderness and pain were evaluated usingnumeric rating scale. Then 0.3 mg /kg of hyoscine was administered intravenously. Using the previous method, rebound tenderness and pain were remeasured fifteen minutes later. Regarding the possibility of negative appendectomy or other diagnoses, 70 patients diagnosed with appendicitis by pathologist were underwent further investigation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Shahid Sadoughi university of medical sciences
Street address
Shahid Sadoughi hospital, Alem Sq, Yazd
City
Yazd
Postal code
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
IR.SSU.MEDICIN.REC.1393.120

Health conditions studied

1

Description of health condition studied
Pain in appendicitis
ICD-10 code
K35-K38
ICD-10 code description
Diseases of appendix

Primary outcomes

1

Description
pain
Timepoint
before and after hyoscine
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
tenderness
Timepoint
before and after hyoscine
Method of measurement
verbal- scorring 1-10

2

Description
rebound tenderness
Timepoint
before and after
Method of measurement
verbal- scoring 1-10

Intervention groups

1

Description
0.3 mg /kg of hyoscine (Matin co- Tehran pharmacology) was administered intravenously. Using the previous method, rebound tenderness and pain were measured fifteen minutes later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid sadoughi hospital
Full name of responsible person
Vahide Salimi
Street address
Shahid Sdoughi hospital, Alem Sq, Yazd
City
Yazd

2

Recruitment center
Name of recruitment center
Shahid Rahnamun hospital
Full name of responsible person
Vahide Salimi
Street address
Shahid Rahnamun hospital, Farrokhu Street, Yazd.
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Shahid Sadoughi University of medical sciences
Full name of responsible person
Vice chancellor for research Shahid Sadoughi University of medical sciences
Street address
Vice chancellor for research Shahid Sadoughi University of medical sciences, Ba Honar sq, Yazd
City
Yazd
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 Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
vahide salimi
Position
residency of emergency medicine
Other areas of specialty/work
Street address
Shahid Sdoughi hospital, Alem Sq, Yazd
City
Yazd
Postal code
Phone
00
Fax
Email
vahideh101052@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
vahide salimi
Position
resident
Other areas of specialty/work
Street address
Shahid Sdoughi hospital, Alem Sq, Yazd
City
Yazd
Postal code
Phone
00
Fax
Email
vahideh101052@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sdoughi hospital
Full name of responsible person
Vahide Salimi
Position
resident of emergency medicine
Other areas of specialty/work
Street address
Shahid Sdoughi hospital, Alem Sq, Yazd
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address
ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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