Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001268134
Ethics application status
Approved
Date submitted
15/07/2019
Date registered
12/09/2019
Date last updated
12/09/2019
Date data sharing statement initially provided
12/09/2019
Date results information initially provided
12/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Dexmedetomidine and Tramadol on Extubation Quality and Postoperative Pain and Agitation in Pediatric Patients Undergoing Adenotonsillectomy Surgery
Scientific title
The Effects of Dexmedetomidine and Tramadol on Extubation Quality and Postoperative Pain and Agitation in Pediatric Patients Undergoing Adenotonsillectomy Surgery
Secondary ID [1] 298667 0
None
Universal Trial Number (UTN)
U1111-1236-6434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenotonsillectomy Surgery 313564 0
Condition category
Condition code
Anaesthesiology 311994 311994 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were taken to pre-operative preparation room with their parents about 30 minutes before the surgical operation. 0.4 mg/kg midazolam was given orally to the all patients in preparation room. Then, patients were monitored and taken to the operation room. Anesthesia was induced with 8% inspired sevoflurane in 50% nitrous oxide and 50% oxygen. After anesthesia induction, sevoflurane concentration is gradually reduced and an intravenous (i.v.) catheter was inserted. Patients were assigned to dexmedetomidine or tramadol group according to a computer generated program as follows: dexmedetomidine group (group D, n = 30) and tramadol group (group T, n = 30). Patients in group D received 1 µg/kg dexmedetomidine and patients in group T received 1.5 mg/kg tramadol. Both of these drugs were administered with a 10-minute i.v. infusion about 10 minutes before the end of the surgery. Patients were monitored, and mean arterial pressure (MAP) and heart rate (HR) were recorded. In addition to these variables, the Riker Sedation-Agitation Scale (SAS) was used for determining the level of anxiety of the patients, and pain point scale was used for determining the level of pain of the patients. Moreover, extubating time which was defined as the time from discontinuation of inhalation agent to removal of the endotracheal tube and extubation quality which was assessed by the presence of the following not breathing (> 20 second), coughing-bucking (frequency =4) and desaturation (saturation of O2 < 95%) after the extubation period were recorded for all patients. Dexmedetomidin group and tramadol groups were compared in terms of these variables. Anaesthetist will be administering the intervention.
Intervention code [1] 314936 0
Treatment: Drugs
Comparator / control treatment
The comparator is tramadol.
Control group
Active

Outcomes
Primary outcome [1] 320639 0
Riker sedation-agitation scale (SAS).
Riker SAS was assesed as follows:
7 (Dangerous agitation) Pulling at endotracheal tube, trying to remove catheters, climbing over bed rail, striking at staff, thrashing side to side
6 (Very agitated) Does not calm, despite frequent verbal reminding of limits; requires physical restraints, biting endotracheal tube
5 (Agitated) Anxious or mildly agitated, attempting to sit up, calms down to verbal instructions
4 (Calm and cooperative) Calm, awakens easily, follows commands
3 (Sedated) Diffi cult to arouse; awakens to verbal stimuli or gentle shaking, but drifts off again; follows simple commands
2 (Very sedated) Arouses to physical stimuli, but does not communicate or follow commands, may move spontaneously
1 (Unable to rouse) Minimal or no response to noxious stimuli, does not communicate or follow commands
Timepoint [1] 320639 0
The following evaluation time points were defined for the Riker Sedation-Agitation Scale:
-1st minute of post operative period
-15th minutes of post operative period
-30th minutes of post operative period
Primary outcome [2] 320640 0
Pain Point Scale
Post-operative pain score was assessed with Pain Point Scale: a 10-point scale (1 point = no pain, and 10 point = unimaginable, unspeakable).
Timepoint [2] 320640 0
The following evaluation time points were defined for the Pain Point Scale
-1st minute of post operative period
-15th minutes of post operative period
-30th minutes of post operative period
Secondary outcome [1] 372294 0
Extubation time
Timepoint [1] 372294 0
Extubating time was defined as the time from discontinuation of inhalation agent to removal of the endotracheal tube.
Extubating time was assessed with tool (a clock). The time was started with the discontinuation of inhalation agent and ended with the removal of the endotracheal tube. The time between this two point was defined as Extubating time.
Secondary outcome [2] 372295 0
Extubation quality
Timepoint [2] 372295 0
Extubation quality was assessed with the following parameters: The presence of the not breathing (greater than 20 second), coughing-bucking (frequency is greater than or equal to 4) and desaturation (saturation of O2 is less than 95%) after the extubation period. These parameters were recorded for all patients. Extubation quality was assessed according to the presence of these parameters. If any of these were not available, it called a quality extubation.
Secondary outcome [3] 372302 0
Mean arterial pressure
Patients were monitored and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with automatic sphygmomanometer. Patient monitoring was started at pre-operative period and was contined until 30 min after operation. MAP was automatically calculated from SBP and DBP vales by patient monitoring.
Its formula was as follows: [(2 x DBP) + SBP] / 3.
Timepoint [3] 372302 0
The following evaluation time points were defined for the MAP:
T0, before induction (basal); T1, 20 min after induction during the procedure; T2, immediately before study drugs infusion (D or T); T3, 5th min. of study drugs infusion; T4, 10th min. of study drugs infusion; T5, 1st min of post extubating; T6, 15st min. of post-operative period; T7, 30st min. of post-operative period.
Secondary outcome [4] 372639 0
Heart rate (HR). Patients were monitored and heart rate was obtained from this monitoring. Patient monitoring was started at pre-operative period and was contined until 30 min after operation. Heart rate was defined as number of beats per minute.
HR was monitored with the patient Monitors (Draeger). From this monitor, HR was assessed.
Timepoint [4] 372639 0
The following evaluation time points were defined for the HR:
T0, before induction (basal); T1, 20 min after induction during the procedure; T2, immediately before study drugs infusion (D or T); T3, 5th min. of study drugs infusion; T4, 10th min. of study drugs infusion; T5, 1st min of post extubating; T6, 15st min. of post-operative period; T7, 30st min. of post-operative period.

Eligibility
Key inclusion criteria
A total of 60 children patients undergoing adenotonsillectomy surgery, aged between 2- 9 years and with American Society of Anesthesiologist (ASA) grades I or II, were included in this randomized study.
Minimum age
2 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of any chronic disease, ASA grades III or higher, blood pressure <100/50 mm Hg, heart rate < 60/bpm and known any allergy to study medications were excluded from the study.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized by a computer-generated scheme (computerised sequence generation) to receive dexmedetomidine or tramadol.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis was conducted with SPSS for Windows version 22.0 (SPSS Inc., Chicago, IL, USA). Continuous data were presented as mean ± standard deviation, and categorical data were presented as percentage. Normality assessment of continuous data were performed with Kolmogorov-Smirnov and/or Shapiro-Wilk tests. Continuous data were compared with Student’s t test for parametric data and Mann Whiyney U test for non-parametric data. Analysis of variance was performed for the comparison of repeated measurements of hemodynamic variables. Post hoc comparisons among the repeated measures in each group were performed by the Tukey HSD and/or LSD method, if appropriate. A value of P < 0.05 was considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
31/10/2012
Date of last data collection
Anticipated
Actual
31/10/2012
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 21673 0
Turkey
State/province [1] 21673 0
Istanbul

Funding & Sponsors
Funding source category [1] 303209 0
Hospital
Name [1] 303209 0
Medeniyet University, Goztepe Training and Research Hospital
Country [1] 303209 0
Turkey
Primary sponsor type
Hospital
Name
Medeniyet University, Goztepe Training and Research Hospital
Address
Ressam Salih Ermez street. No:14, postal code: 34722, Kadikoy/Istanbul
Country
Turkey
Secondary sponsor category [1] 303219 0
None
Name [1] 303219 0
Address [1] 303219 0
Country [1] 303219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303766 0
Medeniyet University, Goztepe Training and Research Hospital Ethic Committee
Ethics committee address [1] 303766 0
Ressam Salih Ermez street. No:14, postal code: 34722, Kadikoy/Istanbul
Ethics committee country [1] 303766 0
Turkey
Date submitted for ethics approval [1] 303766 0
20/06/2012
Approval date [1] 303766 0
28/06/2012
Ethics approval number [1] 303766 0
23/A

Summary
Brief summary
Adenotonsillectomy is a common surgical procedure performed under general anesthesia in childhood. This surgical procedure may cause post-operative pain and agitation. Therefore it is important to provide effective pain control for diminishing post-operative morbidity. Dexmedetomidine and tramadol are among the drugs used for decreasig post-operative pain and agitation. The aim of our study is to compare the effects of dexmedetomidine and tramadol on post-operative pain and agitation, hemodynamic parameters and extubation quality in patients undergoing adenotonsillectomy surgery.
Trial website
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 94722 0
Dr Ikbal Koceroglu
Address 94722 0
Medeniyet University, Goztepe Training and Research Hospital, postal code: 34722, Istanbul, Turkey
Country 94722 0
Turkey
Phone 94722 0
+90 216 280 33 33
Fax 94722 0
Email 94722 0
[email protected]
Contact person for public queries
Name 94723 0
Dr Tugba Bingol Tanriverdi
Address 94723 0
Mehmet Akif Inan Training And Research Hospital, Department Of Anesthesiology, postal code: 63100, Sanliurfa, Turkey
Country 94723 0
Turkey
Phone 94723 0
+905418842232
Fax 94723 0
Email 94723 0
[email protected]
Contact person for scientific queries
Name 94724 0
Dr Tugba Bingol Tanriverdi
Address 94724 0
Mehmet Akif Inan Training And Research Hospital, Department Of Anesthesiology, postal code: 63100,Sanliurfa, Turkey
Country 94724 0
Turkey
Phone 94724 0
+90 5418842232
Fax 94724 0
Email 94724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Full patient confidentiality were taken into account.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Post-operative Riker sedation agitation scale was ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effects of dexmedetomidine and tramadol on post-operative pain and agitation, and extubation quality in paediatric patients undergoing adenotonsillectomy surgery: A randomized trial2019https://doi.org/10.1111/jcpt.13080
N.B. These documents automatically identified may not have been verified by the study sponsor.