Condition category
Signs and Symptoms
Date applied
14/07/2016
Date assigned
25/07/2016
Last edited
25/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes