Comparison of the effect of intravenous ibuprofen, intravenous acetaminophen, and intravenous morphine sulfate on treatment of abdominal pain in patients with appendicitis: a triple blind randomized clinical trial
Objectives: To compare the effect of intravenous ibuprofen, intravenous acetaminophen, and intravenous morphine sulfate on treatment of abdominal pain in patients with appendicitis
Design: A triple blind randomized clinical trial.
Setting and conduct: The eligible patients with appendicitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 60 years; appendicitis; beginning of abdominal pain within past 24 hours.
Exclusion criteria: Pregnancy; using analgesic within past 6 hours; using antibiotic within past 24 hours; chronic abdominal disease; addiction to narcotic; a history of gastrointestinal bleeding; coagulopathy; using medications such as warfarin, lithium, furosemide, or ACEI.
Intervention group 1: Intravenous infusion of ibuprofen 10 mg/kg plus 100 ml normal saline within 30 minutes.
Intervention group 2: Intravenous infusion of morphine sulfate 0.1 mg/kg plus 100 ml normal saline within 30 minutes.
Intervention group 3: Intravenous infusion of acetaminophen 10 mg/kg plus 100 ml normal saline within 30 minutes.
Primary outcome: (a) assessing pain severity before intervention and 15, 30 and 60 minutes after intervention using Visual Analog Scale (VAS); (b) assessing nausea and vomiting before intervention and 15, 30 and 60 minutes after intervention through history taking.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709279014N190
Registration date:2017-09-28, 1396/07/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous ibuprofen, intravenous acetaminophen, and intravenous morphine sulfate on treatment of abdominal pain in patients with appendicitis: a triple blind randomized clinical trial
Public title
Comparison of the effect of intravenous ibuprofen, intravenous acetaminophen, and intravenous morphine sulfate on treatment of abdominal pain in patients with appendicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 60 years; appendicitis; beginning of abdominal pain within past 24 hours.
Exclusion criteria: Pregnancy; using analgesic within past 6 hours; using antibiotic within past 24 hours; chronic abdominal disease; addiction to narcotic; a history of gastrointestinal bleeding; coagulopathy; using medications such as warfarin, lithium, furosemide, or ACEI.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.245
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Assessing pain severity
Timepoint
Before intervention and 15, 30 and 60 minutes after intervention
Method of measurement
Using Visual Analog Scale (VAS)
2
Description
Assessing nausea and vomiting
Timepoint
Before intervention and 15, 30 and 60 minutes after intervention
Method of measurement
Through history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous infusion of ibuprofen 10 mg/kg plus 100 ml normal saline within 30 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of morphine sulfate 0.1 mg/kg plus 100 ml normal saline within 30 minutes.
Category
Treatment - Drugs
3
Description
Intervention group 3: Intravenous infusion of acetaminophen 10 mg/kg plus 100 ml normal saline within 30 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Hila Farokhpey Samami
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Hila Farokhpey Samami
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
hila_kool@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rasool Salimi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
rasoulsl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)