Protocol summary

Summary
The aim of this randomized, double blind clinical trial study was to compare the effects of ketamine and paracetamol for postoperative pain management after total abdominal hysterectomy. After receiving approval from Ethical Committee of Tehran University of Medical Science and written informed consent, we enrolled 80 patients of ASA physical status I-II scheduled for elective total abdominal hysterectomy. Patients with a history of addiction to opiates, known allergy to acetaminophen or ketamine, alcoholism and drug abuse, hepatic disease, sizure and aged below 25 yr and above 65 yr were excluded from the study. patients were assigned to one of two treatment groups according to a computer-generated list of random numbers. Patients in group I, 40 patients, received 1 gr intravenous acetaminophen (Apotel) intraoperatively until skin closure. whereas those in goup II,40 patients , received intravenous bolus ketamine 0.15 mg/kg after extubation. A patient control analgesia device with 15 cc fentanyl and 85 cc normal salin was used to provide postoperative pain relief. Each ml of solution contained 7.5 mcg of fentanyl. The solution infused continuously 4 ml per hour for first 24 hour after surgery. Pain Score, Sedation Score, Blood pressure and heart rate, Nausea and Vomiting and use of additional analgesia evaluated at the PACU and 4, 6, 12, 24 hours after surgery. Pain assessed by Visual Analogue Score (0= no pain, 10= the worst imaginable pain). The demographic characteristics of the two groups data of study recorded on common questionarie form and data sheet. After that, data analysis planed after completion of the trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012103011319N1
Registration date: 2012-12-08, 1391/09/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-08, 1391/09/18
Registrant information
Name
Behzad Behzadi
Name of organization / entity
Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 3137
Email address
b-behzadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of paracetamol and ketamine for post-operative pain management in patients undergoing total abdominal hysterectomy
Public title
Comparison of paracetamol and ketamine for post-operative pain management in patients undergoing total abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 1-Volunteers ages between 25-65; 2- American Society of Anesthesiologist class (ASA) I, II Physical Status; 3- Scheduled for total abdominal hysterectomy surgery; 4- Written informed consent , based on Tehran University Mdical Sciences , Ethical Committee Appproved Study design. Exclusion Criteria: 1-Out of 25-65 ages limitations; 2- Addiction to opiates; 3- Known allergy to acetaminophen or ketamine; 4- History of alcoholism and drug abuse; 5- History of hepatic disease; 6- Dispensing of patient any time after informed consent or lack of patient consent; 7- History of sizure
Age
From 25 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tehran University of Medical Sciences (TUMS)
Street address
Poursina St, Tehran
City
Tehran
Postal code
1445613131
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
130/2035/د/91

Health conditions studied

1

Description of health condition studied
Post operative analgesia after total abdominal hysterectomy
ICD-10 code
Z90.710
ICD-10 code description
Acquired absence of uterus

Primary outcomes

1

Description
Pain
Timepoint
At recovery room, 4, 6, 12 and 24 o'clock after surgery
Method of measurement
Visual Analoge Scsale

Secondary outcomes

1

Description
The patients will evaluate for Sedation, Nausea and Vomiting, additional requirement for analgesia and probable complication during study includes of: pruritus and other complication in both groups.
Timepoint
At recovery room, 4, 6, 12 and 24 o'clock after surgery
Method of measurement
Score of seadtion and nausea and vomiting type and dosage of additional analgesic

Intervention groups

1

Description
Apotel in case group
Category
Treatment - Drugs

2

Description
Ketamine in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-Akram Medical Center
Full name of responsible person
Hamid Reza Feiz M.D
Street address
Department of anesthesiology and pain medicine, Rsoul-Akram Medical Center, Niyayesh St, Sattar Khan Av
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fotouhi
Street address
Tehran University of Medical Sciences (TUMS), Ghods St, Keshavarz Blv,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Tehran University of Medical Sciences (TUMS)
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
Tehran University of Medical ciences
Full name of responsible person
Hamid Reza Feiz
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical enter, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
+98 21 6651 5758
Email
P-Rahimzadeh@tums.ac.irbehzad.behzadi@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Feiz
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical Center, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
+98 21 6651 5758
Email
P-Rahimzadeh@tums.ac.irbehzad.behzadi@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Feiz
Position
Associated Professor, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical Center, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
+98 21 6651 5758
Email
P-Rahimzadeh@tums.ac.irbehzad.behzadi@hotmail.com
Web page address

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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