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Trial registered on ANZCTR


Registration number
ACTRN12616000921482
Ethics application status
Approved
Date submitted
7/04/2016
Date registered
11/07/2016
Date last updated
11/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of intranasal dexmedetomidine versus intranasal ketamine on emergence agitation after sevoflurane anesthesia in myringotomy patients: a randomized clinical trial.
Scientific title
Intranasal dexmedetomidine versus intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing myringotomy : a randomized clinical trial.
Secondary ID [1] 288934 0
nil
Universal Trial Number (UTN)
U1111-1181-5880
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergence agitation after sevoflurane anesthesia in children 298282 0
Condition category
Condition code
Anaesthesiology 298417 298417 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperatively, all patients will be assessed by detailed medical and surgical history, complete clinical examination and routine laboratory investigations and will be allocated randomly into two groups; Group I (intranasal ketamine group = 45 children): Children of this group will receive ketamine intranasal in a dose 5 mg/kg.
Group II (Intranasal dexmedetomidine group = 45 children): Children of this group will receive dexmedetomidine intranasal in a dose 1 microgram/kg.
A preoperative fasting period of 6 hours. No premedication will be taken.
Induction of general anesthesia will done 15 minutes after study drug administration with sevoflurane which will be titrated with increments of 1% at each breath up to 8% in oxygen 100%. Once an appropriate depth of anesthesia will be obtained an IV cannula and a suitable laryngeal mask will be inserted (its position will be confirmed by capnography) and sevoflurane concentration will be reduced to an end tidal concentration of 3% in 100% oxygen. Spontaneous breathing will be allowed provided ETCO2 remained below 50 mm Hg; if ETCO2 exceeded 50 mm Hg, the patient will be excluded from the study and ventilation will be assisted. No muscle relaxant or narcotic will be administered during the procedure. The patients will be monitored continuously for heart rate, oxygen saturation, respiratory rate, end tidal CO2 and mean arterial blood pressure. Sevoflurane will be discontinued immediately after insertion of the T-tube, and the laryngeal mask will be removed 60 seconds later and the patient will be transported to the post-anesthesia care unit (PACU) in a quiet and warm environment without any stimulus. Parents will be allowed to be at the child’s bedside in the PACU.
Intervention code [1] 294405 0
Prevention
Intervention code [2] 294640 0
Treatment: Drugs
Comparator / control treatment
Group II (Intranasal dexmedetomidine group = 45 children): is the active control group, Children of this group will receive dexmedetomidine intranasal in a dose of 1 micro-gram/kg.
Control group
Active

Outcomes
Primary outcome [1] 297898 0
The incidence of EA was evaluated using Aono's four point scale 1= calm; 2= not calm but could be easily consoled; 3= moderately agitated or restless and not easily calmed; 4= combative, excited, or disoriented, thrashing around. Scores of three and four will be considered as presence of EA, while one and two as absence of EA.
Timepoint [1] 297898 0
5 minutes after awakening
Primary outcome [2] 297908 0
The pediatric anesthesia emergence delirium (PAED) scale will be used to evaluate the severity of EA , a five-point rating scale (eye contact, purposeful actions, awareness of surroundings, restlessness and consolability), with five grades(0 to 4) for each item. The total score (20) is the sum of the scores of the individual items. The severity of EA increases proportional to the total score. A score = 10 will be considered agitated, and will be treated with i.v propofol 1 mg/kg as rescue medication. A score = 15 reflects severe agitation while, scores less than 10 means no agitation.
Timepoint [2] 297908 0
The severity of EA will be evaluated at Time 0 , 5, 10, 15 and 30 min after awakening .
Secondary outcome [1] 322591 0
Duration of emergence in minutes
Timepoint [1] 322591 0
The time interval from switching off sevoflurane to spontaneous eye opening, the ability to obey commands after and purposeful movements .
Secondary outcome [2] 322593 0
Occurrence of complications: e.g. nausea, vomiting, bradycardia, Cough, laryngospasm, or desaturation (SpO2 below 95%), or any other complication will be treated , recorded and cleared to the ethical committee on time.
Timepoint [2] 322593 0
from the time of drug administration till 30 minutes after awakening
Secondary outcome [3] 322594 0
The response to parental separation will be assessed using parental separation anxiety scale; excellent (1):child cooperative, unafraid or asleep. Good (2): the child is slightly afraid/crying and quiet with reassurance. Fair (3): the child is moderately afraid and no response to reassurance. Poor (4): the child is crying and needs restraint .
Timepoint [3] 322594 0
15 minutes after drug administration
Secondary outcome [4] 322596 0
The response to face mask induction will be evaluated using the mask acceptance scale; 1= combative, crying, 2= not easily calmed, moderate fear of mask, 3 = cooperative with reassurance, 4 = cooperative and calm .
Timepoint [4] 322596 0
at the time of induction of anesthesia

Eligibility
Key inclusion criteria
Patients prepared to unilateral or bilateral myringotomy
Both sexes, age from 3 to 6 years old.
ASA physical status I or II.
Minimum age
3 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a -Parent's refusal.
b- Preoperative agitation (e.g. cerebral palsy, agitation…etc).
c - Children with allergy to ketamine, dexmedetomidine.
d - Aberrant nasal deformity or nasal trauma.
e - Acute (e.g. running nose or upper respiratory tract infection) or chronic nasal problems.
f -Mental retardation, physical developmental delay, or neuromuscular disease.
g - Patients under treatment with sedatives or anticonvulsants.
h - Respiratory and cardiovascular diseases.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7794 0
Egypt
State/province [1] 7794 0
Tanta, Elgharbia governorate

Funding & Sponsors
Funding source category [1] 293305 0
Hospital
Name [1] 293305 0
Tanta University Hospital.
Address [1] 293305 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital,faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257

Country [1] 293305 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country
Egypt
Secondary sponsor category [1] 292118 0
None
Name [1] 292118 0
Address [1] 292118 0
Country [1] 292118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294781 0
The research Ethics Committee of the Faulty of Medicine ,Tanta University, Egypt.
Ethics committee address [1] 294781 0
El Geesh street, Faulty of medicine ,Tanta University, Egypt.
Postal code: 31257
Ethics committee country [1] 294781 0
Egypt
Date submitted for ethics approval [1] 294781 0
04/01/2016
Approval date [1] 294781 0
01/02/2016
Ethics approval number [1] 294781 0
30758/02/16

Summary
Brief summary
The aim of this prospective randomized study is to compare the effect of intranasal dexmedetomidine and intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients scheduled for myringotomy operations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52926 0
A/Prof Hoda Alsaid Ahmed Ezz
Address 52926 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52926 0
Egypt
Phone 52926 0
+20 1222768250
Fax 52926 0
Email 52926 0
hoda.ezz@med.tanta.edu.eg
Contact person for public queries
Name 52927 0
Prof Abd El Raheem M. Dowidar
Address 52927 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52927 0
Egypt
Phone 52927 0
+20 12223195015
Fax 52927 0
Email 52927 0
dr.dowidar47@hotmail.com
Contact person for scientific queries
Name 52928 0
Prof Abd El Raheem M. Dowidar
Address 52928 0
El Geesh street, Department of Anesthesia and surgical ICU, Tanta University Hospital, faculty of Medicine,Tanta University, Tanta, Elgharbia Governorate, Egypt.
The postal code:31257
Country 52928 0
Egypt
Phone 52928 0
+20 12223195015
Fax 52928 0
Email 52928 0
dr.dowidar@med.tanta.edu.eg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary