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Trial registered on ANZCTR


Registration number
ACTRN12616001522404
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
4/11/2016
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does ketamine improve the quality of sedation of intranasal dexmedetomidine premedication in children
Scientific title
The effects of ketamine on the quality of sedation of intranasal dexmedetomidine premedication in children undergoing elective tonsillectomy.
Secondary ID [1] 288457 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tonsillitis 298633 0
Condition category
Condition code
Respiratory 298698 298698 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GroupDK received 2mg/kg intranasal dexmedetomidine and 2mg/kg intranasal ketamine premedication 30 min before general anaesthesia;the intervention and the participants will be monitored throughout the duration of the procedure
Intervention code [1] 293790 0
Treatment: Drugs
Comparator / control treatment
GroupD received 2mg/kg intranasal dexmedetomidine premedication
30min before general anaesthesia
Control group
Active

Outcomes
Primary outcome [1] 297213 0
Sedation state will be evaluated by Modified Observer’s Assessment of Alertness/Sedation Scale(MOAA/S).
Timepoint [1] 297213 0
Sedation state will be evaluated at 30min after premedication.
Secondary outcome [1] 320368 0
Response to stimulation will be evaluated by Mask Acceptance Scale(MAS).
Timepoint [1] 320368 0
Response to stimulation will be evaluated at 30min after premedication.
Secondary outcome [2] 323424 0
Anxiety state will be evaluated by Parental Separation Anxiety Scale (PSAS).
Timepoint [2] 323424 0
Anxiety state will be evaluated at 30min after premedication.
Secondary outcome [3] 325224 0
The onset time is defined as the time from after premedication until the disappearance of eyelash reflex.The time of premedication and the time of the disappearance of eyelash reflex are recorded in a note.
Timepoint [3] 325224 0
at time of onset of anaesthesia
Secondary outcome [4] 325225 0
The time of extubation is defined as the time from discontinuation of anesthesia until the tracheal catheter was extubated. The time of extubation is recorded in a note.
Timepoint [4] 325225 0
at the time of extubation
Secondary outcome [5] 325226 0
The duration of PACU stay is defined as the time from the child entered PACU until he or she was ready to be discharged. It is assessed by review of medical records.
Timepoint [5] 325226 0
at time of PACU discharge
Secondary outcome [6] 325227 0
Emergence agitation will be evaluated by the Pediatric Anesthesia Emergence Delirium (PAED) scale. Emergence agitation is defined as the PAED scale >=10.
Timepoint [6] 325227 0
Emergence agitation will be assesed at the emergence time.
Secondary outcome [7] 325228 0
All episodes of postoperative nausea and vomiting will be recorded through direct questioning by one anesthesiologist unaware of the type of medications given to the patients. Vomiting is defined as either vomiting (expulsion of stomach contents) or retching
(an involuntary attempt to vomit but not productive as regards stomach contents). Nausea is defined as a subjectively unpleasant sensation associated with awareness of the urge to vomit.
Timepoint [7] 325228 0
the first 24 h after surgery
Secondary outcome [8] 325229 0
Cardiocap/5 is used to measure the heart rate during the time before premedication to the end of the operation. Bradycardia (30% lower than the basic value) need to be recored .
Timepoint [8] 325229 0
Bradycardia need to be recored every 5 minutes for the duration of the procedure.
Secondary outcome [9] 325767 0
Cardiocap/5 is used to measure the blood pressure during the time before premedication to the end of the operation. Hypotension (30% lower than the basic value) need to be recored .
Timepoint [9] 325767 0
Hypotension need to be recored every 5 minutes for the duration of the procedure.

Eligibility
Key inclusion criteria
Children were engaged in this study, who were with American Society of Anesthesiologists (ASA) physical status I or II, aged between 3 and 7 years old and scheduled to undergo elective tonsillectomy.
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children were excluded from the study if they had significant renal or hepatic disorders, dysrhythmias, recent upper respiratory infection, asthma, nasal pathology, allergy or hypersensitive reaction to dexmedetomidine or ketamine, therapy of opioid or non-steroidal anti-inflammatory drug in the 24 hours prior to the study, and a medical history of mental illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2016
Actual
3/01/2017
Date of last participant enrolment
Anticipated
20/01/2017
Actual
20/10/2017
Date of last data collection
Anticipated
24/01/2017
Actual
23/10/2017
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 7593 0
China
State/province [1] 7593 0
Fujian

Funding & Sponsors
Funding source category [1] 292892 0
Hospital
Name [1] 292892 0
Fujian Provincial Hospital
Country [1] 292892 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Country
China
Secondary sponsor category [1] 291635 0
Hospital
Name [1] 291635 0
Fujian Provincial Hospital
Address [1] 291635 0
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Country [1] 291635 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294502 0
The Biological-Medical Ethical Committee of Fujian Provincial Hospital
Ethics committee address [1] 294502 0
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Ethics committee country [1] 294502 0
China
Date submitted for ethics approval [1] 294502 0
13/01/2016
Approval date [1] 294502 0
25/02/2016
Ethics approval number [1] 294502 0
K-2016-02-11

Summary
Brief summary
Undergoing surgery can be a significant traumatic experience for younger children. Furthermore, preoperative crying increase the respiratory tract secretion and stress response, leading to increased heart rate (HR), blood pressure and airway hyperactivity.In order to reduce anxiety and promote the separation of parents, a variety of drugs have been advocated as premedication. Children's ideal preoperative medication should be easy to accept, fast and reliable with the minimum adverse effect. Dexmedetomidine is a selective a2 adrenergic agonist that produces analgesia as well as sedation effects via actions in the locus ceruleous without respiratory depression. Its induced sedation is similar to natural sleep, which is characterized by an easy and quick arousal. Dexmedetomidine also has some special pharmacodynamic properties, including decreased minimum alveolar concentration(MAC) and a conspicuous reduction in catecholamine secretion. Dexmedetomidine may be a suitable auxiliary medicine of ketamine, because it alleviates the cardiovascular stimulation effect of ketamine. Ketamine is the most commonly used drug for children that acts as an N-methyl-d-aspartate receptor antagonist with sedative, anesthetic, analgesic and amnesic effects and dissociation from the environment. The aim of this study was to evaluate and compare the sedative effect and safety of intranasal dexmedetomidine, intranasal ketamine and dexmedetomidine as a premedication before induction of anesthesia in pediatric tonsillectomy. Sixty children (both boys and girls) were engaged in this study, who were with ASA physical status I or II, aged between 3 and 7 years old and scheduled to undergo elective tonsillectomy. The subjects were randomly divided into two groups with thirty children each. Group Dexmedetomidine (Group D)received premedication of dexmedetomidine 2ug/kg 45 min before induction by LMA MAD. Group Dexmedetomidine + Ketamine (Group DK) received premedication of intranasal combined dexmedetomidine 2ug/kg and ketamine 2mg/kg. Sedation status was evaluated by the observer using the Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S) at the baseline before premedication and 30 min after premedication. Patient’s response to separation from parents was assessed by the Parental Separation Anxiety Scale (PSAS), about 30 minutes after medication administration. After the patient was sent to operating room, the Patient’s Mask Acceptance Scale (MAS) score was calculated. Vital signs were continuously monitored and recorded every 15min until the child was ready to be discharged.The primary outcome of our study was the sedation score. The secondary outcomes included the separation from parents, facemask acceptance, oneset time, the time of extubation, duration of PACU stay, emergence agitation, and the incidence of adverse effects, such as nausea,vomiting. Bradycardia and hypotension (30% lower than the basic value) need to be recored during the operation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 789 789 0 0
/AnzctrAttachments/369976-Ethics approval forms.pdf

Contacts
Principal investigator
Name 62962 0
A/Prof Yusheng Yao
Address 62962 0
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Country 62962 0
China
Phone 62962 0
+86-13559939629
Fax 62962 0
Email 62962 0
[email protected]
Contact person for public queries
Name 62963 0
Yusheng Yao
Address 62963 0
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Country 62963 0
China
Phone 62963 0
+86-13559939629
Fax 62963 0
Email 62963 0
[email protected]
Contact person for scientific queries
Name 62964 0
Yusheng Yao
Address 62964 0
No.134,Dongjie,Fujian Provincial Hospital,Fuzhou,Fujian,China,350004,
Country 62964 0
China
Phone 62964 0
+86-13559939629
Fax 62964 0
Email 62964 0
[email protected]

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