Effects of tramadol and dexmedetomidine on recovery in pediatric patients undergoing adenotonsillectomy

ISRCTN ISRCTN89326952
DOI https://doi.org/10.1186/ISRCTN89326952
Secondary identifying numbers EUEC-2011/135
Submission date
14/07/2016
Registration date
25/07/2016
Last edited
09/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Nurdan Bedirli
Scientific

Gazi University, Medical Faculty
Anesthesiology department
Ankara
06510
Türkiye

ORCiD logoORCID ID 0000-0003-2624-0259
Phone +90 5324002824
Email tip@gazi.edu.tr

Study information

Study designProspective single-centre randomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTramadol vs dexmedetomidine for emergence reaction control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: Prospective randomised controlled clinical study
Study objectivesThe 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(s)Erciyes University Research Ethics Committee, 01/03/2011, ref: 2011/135
Health condition(s) or problem(s) studiedPostoperative pain after adenotonsillectomy
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)1. Tramadol 2. Dexmedetomidine
Primary outcome measurePain 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 measures1. 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 study start date01/01/2011
Completion date01/01/2016

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit12 Years
SexBoth
Target number of participantsEighty patients
Total final enrolment77
Key inclusion criteria1. Patients ASA physical status I-II
2. Aged between 2 and 12
3. Undergoing adenotonsillectomy
Key exclusion criteria1. Developmental delay
2. Cardiac disorder
3. Psychological disorder
3. Epilepsy
4. Allergy to study medications
Date of first enrolment01/01/2013
Date of final enrolment01/01/2015

Locations

Countries of recruitment

  • Türkiye

Study participating centre

Gazi University, Medical Faculty
Anesthesiology Department
Ankara
06510
Türkiye

Sponsor information

Gazi university, Medical Faculty
Hospital/treatment centre

Gazi Üniversty Tıp fakültesi Bashekimlgi
Emniyet mahallesi
Besevler
Ankara
06560
Türkiye

Phone +90 3122025312
Email nurbedirli@gazi.edu.tr
ROR logo "ROR" https://ror.org/054xkpr46

Funders

Funder type

University/education

Gazi University, Medical faculty

No information available

Results and Publications

Intention to publish date01/01/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/03/2017 09/08/2019 Yes No

Editorial Notes

09/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.