Objectives: This study is aimed to assess of the effect sole paracetamol for pain control after knee arthroscopy surgeries.
Design: Prospective randomized clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: Fifty patients, with age 15-60yr; ASA Class I- II, undergoing knee arthroscopy surgeries in Akhtar hospital during 2014-2015,were included .
Patients were randomized into two groups of 25 each, using a table of random numbers.
Intervention: Study group, patients received paracetamol 2 g IV infusion over 15 minutes every 6 hours for 24 hours.
control group, patients received morphine in morphine Patient-controlled analgesia (PCA) pump, at the request of the patient 1 mg/ mL bolus with a minimum interval of 6 min.
Main outcome measures (variables): Postoperative pain
The drug study are coded and delivered to the patients by and individual not aware of the research process. A blind stuff was coded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112415515N1
Registration date:2014-09-23, 1393/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect sole paracetamol for pain control after knee arthroscopy surgeries
Public title
The effect of paracetamol for pain control after knee arthroscopy
surgeries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 15-60 yr;ASA Class I- II; Arthroscopic knee surgery under epidural anesthesia.
Exclusion criteria: Taking any pain medication 24 hours before surgery; Patients unable or unwilling to use patient-controlled analgesia (PCA); Liver failure; Kidney failure; Severe cardiopulmonary; Coagulopathy; Obesity morbid; History of postoperative nausea and vomiting; History of migraine; History of complications during and after surgery; Postoperative complications in the first 24 hours that may require intervention; Known allergies; Sensitivity or contraindication for opioid and non opioid drugs; Pregnancy and lactation; Substance abuse.
Age
From 78 years old to 33 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shahid Beheshti University of Medical Sciences
Street address
Tabnak S.
City
Tehran
Postal code
Approval date
2014-08-17, 1393/05/26
Ethics committee reference number
92/11/10 /م/432
Health conditions studied
1
Description of health condition studied
Acute pain management after knee arthroscopy
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score
Timepoint
Arrival in the recovery room, 15 and 30 min, 1, 2, 4, 6, 12, 18 and 24 hours after study drug administration.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
First 24 hours after surgery
Method of measurement
Based on the patient's questions
2
Description
Amount of analgesia used
Timepoint
First 24 hours after surgery
Method of measurement
Based on the patient's questions
3
Description
Side effect
Timepoint
First 24 hours after surgery
Method of measurement
Based on the patient's questions
4
Description
Nausea and vomiting
Timepoint
Arrival in the recovery room, 15 and 30 min, 1, 2, 4, 6, 12, 18, 24 h after initiation of study drug
Method of measurement
Based on the score of 1-4
5
Description
Sedation score
Timepoint
Arrival in the recovery room, 15 and 30 min, 1, 2, 4, 6, 12, 18, 24 h after initiation of study drug
Method of measurement
Ramsay scale
Intervention groups
1
Description
In the study group, Intravenous infusion of 2 g paracetamol
Category
Prevention
2
Description
In the control group, Morphine PCA pump
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Masoud Hashemi MD.
Street address
Sharifimanesh Ave., Romi Bridge, Shariati Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences