Protocol summary

Summary
We are going to assess the effect of intravenous paracetamol on postoperative nausea and vomiting during the first 24 hr after strabismus surgery in pediatric patients aged between 2-12 years in Farabi hospital. After approval by the University Research Ethics Committee and obtaining written informed consent from the parents, 120 children scheduled for strabismus surgery under general anesthesia will be included in this prospective, randomized, double-blind clinical study. Children with hepatic or renal failure, allergy to study drugs, history of motion sickness, previous severe postoperative nausea and vomiting and current use of antiemetic drugs will be excluded from the study. Age, sex, weight and height will be recorded. Induction of general anesthesia will be done with fentanyl 1µ/kg, sodium thiopental 3-5mg/kg, lidocaine 1mg/kg, and a laryngeal mask airway (LMA) will be inserted. All patients will receive intravenous dexamathasone 0.1 mg/kg after induction and then will be studied in two groups. Anesthesia will be maintained with isoflurane 1-1.5% and O2/air (FiO2=50%) and half saline solution with a rate of 10cc/kg/hr will be infused. At the end of the surgery intravenous infusion of paracetamol 15mg/kg (1.5ml/kg of 1 gram paracetamol in 100 cc normal saline) or nomal saline with the same volume (1.5cc/kg) will be performed in 20 minutes in intervention or control group respectively . Two or more vomiting episodes will be treated with ondansetrone 0. 1mg/kg. The Facial Pain Scale will be used to measure postoperative pain after surgery and if the pain score to be measured is 3 or more, the patient will receive acetaminophen with a dose of 10mg/kg. Nausea and vomiting and pain score will be assessed in post-anesthesia care unit and in ward in 6-12 and 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310218768N2
Registration date: 2014-05-20, 1393/02/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mahshid Nikooseresht
Name of organization / entity
Hamadan university of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 5383
Email address
nikooseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research of Tehran university of medical science
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of intravenous paracetamol on post operative pain and nausea and vomiting in pediatric patients undergoing strabismus surgery
Public title
The effect of paracetamol on post operative pain, nausea and vomiting after strabismus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged between 2 and 14 years, ASA physical status I and II scheduled for strabismus surgery under general anaesthesia Exclusion criteria: Those with hepatic or renal failure, known allergy to study drugs, those with a history of previous PONV or motion sickness, using antihistamine or antiemetic drugs or steroids in previous 24 hours before surgery,
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2013-01-15, 1391/10/26
Ethics committee reference number
210.22396.د.91

Health conditions studied

1

Description of health condition studied
acute postoperative pain
ICD-10 code
R52.0A
ICD-10 code description
Acute pain

2

Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
In recovery, 6 hours after surgery, 12 hours after surgery, 24 hours after surgery
Method of measurement
Questionare

2

Description
Pain score
Timepoint
In recovery, 6 hours after surgery, 12 hours after surgery, 24 hours after surgery
Method of measurement
Facial pain scale

Secondary outcomes

1

Description
Rescue analgesic dose
Timepoint
After 24 hours
Method of measurement
Questionare

2

Description
Rescue ondansetrone dose
Timepoint
24 hours after surgery
Method of measurement
Questionare

Intervention groups

1

Description
control group: Intravenous infusion of normal saline(1.5ml/kg) in 20 minutes at the end of surgery. Two or more vomiting episodes will be treated with ondansetrone 0. 1mg/kg. The Facial Pain Scale will be used to measure postoperative pain after surgery and if the pain score to be measured is 3 or more, the patient will receive acetaminophen with a dose of 10mg/kg. Nausea and vomiting and pain score will be assessed in post-anesthesia care unit and in ward in 6-12 and 24 hours after surgery.
Category
Treatment - Drugs

2

Description
Intervention group: Intravenous infusion of paracetamol 15mg/kg (1.5ml/kg of 1 gram paracetamol in 100 cc normal saline) in 20 minutes at the end of surgery. Two or more vomiting episodes will be treated with ondansetrone 0. 1mg/kg. The Facial Pain Scale will be used to measure postoperative pain after surgery and if the pain score to be measured is 3 or more, the patient will receive acetaminophen with a dose of 10mg/kg. Nausea and vomiting and pain score will be assessed in post-anesthesia care unit and in ward in 6-12 and 24 hours after surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Hamid Zahedi
Street address
Anesthesiolgy Department, Farabi hospital, Qazvin Square, South Kargar Ave, Tehran, Iran
City
Teharn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research of Tehran university of medical science
Full name of responsible person
Dr. Yunesiyan
Street address
Sixth floor, central bulding of Tehran university of medical science, Ghods Aven, Keshavarz Blvd., Tehran, Iran
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 of Tehran university of medical science
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
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nkooseresht M.D
Position
Assistant Professor of Anesthsiology, Fellowship of Pain managenent
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat hospital, ,Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1264 0049
Fax
Email
nikooseresht@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht M.D
Position
Assistant Professor of Anesthesiology, Fellowship of Pain management
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1264 0049
Fax
Email
nikooseresht@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht M.D
Position
Assistant Professor of Anesthesiology, Fellowship of Pain management
Other areas of specialty/work
Street address
Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Postal code
6514845471
Phone
+98 81 1264 0049
Fax
Email
nikooseresht@umsha.ac.ir
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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