Plain English Summary
Background and study aims
An adenotonsillectomy is a common surgical procedure in which the small lumps of tissue at the back of the throat and nose (tonsils and adenoids) are removed. The tonsils and adenoids are part of the immune system they are not essential, and their removal does not damage the immune system in any way. The procedures are very simple and safe, and one of the most common complications is the agitation the child feels when they wake up from general anesthesia (being put to sleep for the operation). This puts a child at risk of hurting themselves, a longer stay in hospital, extra nursing care requirements, the family not being happy with the treatment and increased costs. In order to prevent this problem, giving extra medications as well as the general anesthesia is the standard approach. The aim of this study is to compare the effects of two commonly used drugs on agitation upon waking from general anesthesia (emergence agitation).
Who can participate?
Patients aged between 2-12 years who are having their tonsils and adenoids removed.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given dexmedetomidine (a sedative) mixed with normal saline (salt water) through a drip over a 10 minute period. Those in the second group receive tramadol (a pain-reliever) mixed with normal saline (salt water) through a drip over a 10 minute period. Participants in both groups are put to sleep for their surgery the same way and have their vital signs (such as heart rate, breathing and blood pressure) measured throughout surgery. Participants in both groups are then observed by clinical staff in the recovery area for an hour after their surgery to look for signs of emergence agitation.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with taking part in this study.
Where is the study run from?
Gazi University, Medical Faculty (Turkey)
When is the study starting and how long is it expected to run for?
January 2011 to January 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Andrew Hayward
a.hayward@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Nurdan Bedirli
ORCID ID
http://orcid.org/0000-0003-2624-0259
Contact details
Gazi University
Medical Faculty
Anesthesiology department
Ankara
06510
Turkey
+90 5324002824
tip@gazi.edu.tr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EUEC-2011/135
Study information
Scientific title
Tramadol vs dexmedetomidine for emergence reaction control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: Prospective randomised controlled clinical study
Acronym
Study hypothesis
The aim of this study is to evaluate the hypothesis that tramadol would control emergence agitation of sevoflurane as efficient as dexmedetomidine in pediatric patients undergoing adenotonsillectomy.
Ethics approval
Erciyes University Research Ethics Committee, 01/03/2011, ref: 2011/135
Study design
Prospective single-centre randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Postoperative pain after adenotonsillectomy
Intervention
Patients are randomised to one of two groups according to a computer generated random numbers table.
Group 1: After intubation, patients receive 1 µg/kg dexmedetomidine diluted in saline (2 ml of dexmedetomidine and 8 ml of saline) administered as a single IV dose over a 10 minute period.
Group 2: After intubation, patients receive 2 mg/kg tramadol diluted in saline 4 ml of tramadol and 6 ml of saline) administered as a single IV dose over a 10 minute period.
Standard anesthesia monitoring includes electrocardiogram, noninvasive blood pressure, pulse oximetry, and inspiratory and expiratory gas concentrations are applied to all the patients in both group during the surgery. Heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), and minimum alveolar concentration (MAC) are also recorded before induction (baseline), at induction and every 5 minutes after induction during the procedure.
After the end of the procedure at the post anesthesia care unit (PACU) the intensity of pain is assessed using a modified Hannallah pain score and observational pain score (OPS), pediatric anesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS). HR, MAP, SpO2 are measured and recorded on arrival to PACU and 5, 10, 15, 30, 45, 60 minutes after arrival to PACU. Any adverse effects such as vomiting, airway obstruction, laryngospasm or bronchospasm are also recorded.
Intervention type
Drug
Phase
Phase IV
Drug names
1. Tramadol
2. Dexmedetomidine
Primary outcome measure
Pain intensity is assessed using a modified Hannallah pain score and observational pain score (OPS), pediatric anesthesia emergence delirium (PAED) scale, Ramsay sedation score (RSS) on arrival to PACU and 5, 10, 15, 30, 45, 60 minutes after arrival to PACU.
Secondary outcome measures
1. Heart rate is measured before induction (baseline), at induction and every 5 minutes after induction during the procedure
2. Mean arterial pressure is meaured before induction (baseline), at induction and every 5 minutes after induction during the procedure
3. Adverse events are monitored through clinical observations on arrival to PACU and 5, 10, 15, 30, 45, 60 minutes after arrival to PACU
Overall trial start date
01/01/2011
Overall trial end date
01/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients ASA physical status I-II
2. Aged between 2 and 12
3. Undergoing adenotonsillectomy
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Eighty patients
Total final enrolment
77
Participant exclusion criteria
1. Developmental delay
2. Cardiac disorder
3. Psychological disorder
3. Epilepsy
4. Allergy to study medications
Recruitment start date
01/01/2013
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Turkey
Trial participating centre
Gazi University, Medical Faculty
Anesthesiology Department
Ankara
06510
Turkey
Sponsor information
Organisation
Gazi university, Medical Faculty
Sponsor details
Gazi Üniversty Tıp fakültesi Bashekimlgi
Emniyet mahallesi
Besevler
Ankara
06560
Turkey
+90 3122025312
nurbedirli@gazi.edu.tr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Gazi University, Medical faculty
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
01/01/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28283018 (added 09/08/2019)