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Comparison of intravenous and rectal acetaminophen for postoperative pain control in children following Adenotonsillectomy

Protocol summary

Summary
The aim of this study is to compare analgesic efficacy of intravenous injection of acetaminophen with rectal acetaminophen for postoperative tonsillectomy. In this double-blind randomized clinical trial, 70 patients (3-14 y) with American society of Anesthesiologists (ASA) status I and II will be recruited. Patients with emergency operation, allergy to acetaminophen, concurrent diseases, convulsion, precedence of chronic pain and consumption of analgesics and Acetaminophen in the past two weeks will be excluded from study. The patients are randomized in two groups who receive intravenous Acetaminophen (15mg/kg) or rectal acetaminophen (40mg/kg) after anesthesia induction. The induction and maintenance of anesthesia will be same in both groups. The post-operative pain will be evaluated by Wong-Baker Face Pain Scale (FPS). The homodynamic changes, as well as possible complications will also be determined during first 24 hours hospital stay. The observer and the patients will be blind to the groups. In the recovery room HR,SBP,DBP will be recorded every 15 minutes, pain score (face scale), agitation, Aldret score will be recorded every 15 minutes. When the patients obtain score 8 they will leave recovery room. After operation in the ward, pain score will be measured every 4 hours. In recovery, patients with score of less than 5 will receive IV Fentanyl 0.5 µg/kg and time of receiving analgesic will be recorded. Children will be discharged after 24 hours.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108194041N5
Registration date: 2011-09-08, 1390/06/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-09-08, 1390/06/17
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous and rectal acetaminophen for postoperative pain control in children following Adenotonsillectomy
Public title
Comparison of intravenous and rectal acetaminophen for postoperative pain control in children following Adenotonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASAI,II children; 3-14 years old;candidated for adenotonsilectomy in Tabriz Children Hospital. Exclusion criteria: emergency surgery; known allergy to Acetaminophen; history of renal, hepatic, cardiac, respiratory tract diseases; epilepsy; neuromuscular disease; history of chronic pain with analgesic usage & acetaminophen in last 2 week.
Age
From 3 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Tabriz University of Medical Sciences
Street address
Golgasht st.
City
Tabriz
Postal code
5136735886
Approval date
2011-04-05, 1390/01/16
Ethics committee reference number
9026

Health conditions studied

1

Description of health condition studied
pain afte adenotonsilectomy
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids

Primary outcomes

1

Description
pain after adenotonsilectomy
Timepoint
in recovery every 15 min,in ward every 4 hr
Method of measurement
face pain sceale

Secondary outcomes

1

Description
amount of analgesic usage
Timepoint
every 15 min in recovery ,every 4 hr in ward
Method of measurement
mg/kg

Intervention groups

1

Description
control group: IV acetaminophen 15mg/kg
Category
Treatment - Drugs

2

Description
Interventionl group: rectal acetaminophen 40mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Tabriz Children Hospital, Sheshkelan st.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ostad Rahimi
Street address
Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com ; seidhejazie@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
board of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.comseidhejazie@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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