Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001518853
Ethics application status
Approved
Date submitted
1/11/2020
Date registered
9/11/2021
Date last updated
3/10/2023
Date data sharing statement initially provided
9/11/2021
Date results provided
9/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of perioperative active warming on post-operative pain and shivering in pre-schoolers
Scientific title
The influence of perioperative active warming on post-operative pain and shivering in pre-schoolers
Secondary ID [1] 302670 0
19102062- This trial is sponsored by Selcuk University's coordinatorship office of scientific research projects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 319588 0
postoperative shivering 319589 0
postoperative hypothermia 319590 0
Condition category
Condition code
Anaesthesiology 317528 317528 0 0
Pain management
Anaesthesiology 317529 317529 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in group A- they were heated with forced air warmer during preoperative and postoperative period- were managed with administrations following respectively.
Firstly, Patients preparing in the service to go to the operating room were blanketed with the special apron of the device(forced air warmer) and the device was set up to 43 °C. Patients were heated until they were taken to the operating table throughout 30 minutes at least by the researcher. During the warming core body temperature were measured via the zero heat flux thermometer.
Secondly, When the patients were taken to the operating table, heating with a forced air warmer was terminated by the researcher. The patients were warmed from the beginning to the end of the anesthesia with a carbon fiber blanket that was previously activated at 38 °C, and the temperature was monitored via the zero heat flux thermometer.
Finally, during the postoperative period, after coming out of anesthesia, warming with a carbon fiber blanket was terminated and warming with forced air warmer was restarted and gone on until the patient dressed his/her own clothes. Throughout the whole active warming process, preoperatiively and postoperatively, warmer device was turned off when the core temperature of the patient reached to 37.5 °C and it was turned on again when the temperature mentioned before reached below of the 36.5 °C.
Intervention code [1] 318953 0
Prevention
Intervention code [2] 321230 0
Treatment: Devices
Comparator / control treatment
In control group, almost everything was the same of intervention except preoperative and postoperative warming. Whilst the warming was performed by means of a forced air blanket in the intervention group, it was provided via a green sheet heated previously in the control group (this green sheet is usually used with the aim of covering the surgical area and providing a sterile environment to the surgeon).
Control group
Active

Outcomes
Primary outcome [1] 325562 0
core body temperature
core body temperature were measured via the zero heat flux thermometer
Timepoint [1] 325562 0
preoperative, 0,15,30,45 and 60 minutes during the operation, 0,15 and minutes later than anesthesiology
Secondary outcome [1] 388397 0
pain
Pain was assessed by means of FLACC scale including Face, Leg, Activity, Cry and Consolability.
Timepoint [1] 388397 0
0 and 30 minutes later than anesthesiology and 6 hours later than anesthesiology
Secondary outcome [2] 388398 0
shivering
Shivering was considered using the scale devised by Crossley and Mahajan
Timepoint [2] 388398 0
0 and 30 minutes later than anesthesiology and 6 hours later than anesthesiology
Secondary outcome [3] 398774 0
Agitation
WATCHA scale was used for the assessment of postanesthetic agitation.
Timepoint [3] 398774 0
0,30 and 60 minutes later than recovery of Anesthesia

Eligibility
Key inclusion criteria
-patients between 2-6 years old
-duration of anesthesiology; more than 1 hour
-elective surgical procedures
-ASA(American Society of Anesthesiologists) I,II patients
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with fever
-open abdominal, thoracic and cranial surgical procedures
-urgent surgical procedures

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)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation technique was used for randomisation of groups of this trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Postoperative shivering incidence was found % 29.83 by Liu et all. And sample size was determined as 35 patients to decrease the insidence to %5 with %80 power and %95 confidence.(Liu et all 2017 in Medicine) That's why we decided to include 35 patients for each group. And we included 70 patients to trial totaly.. We used IBM SPSS Version 21 for statistical analyses of the trial. Student t test was done to determine the statistical significance between variables in the group A and B when the normallity test was normal. On the other hand Mann whitney U test was done when the normallity test was not normal.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2020
Date of last participant enrolment
Anticipated
Actual
30/09/2020
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 23082 0
Turkey
State/province [1] 23082 0
Konya

Funding & Sponsors
Funding source category [1] 307109 0
University
Name [1] 307109 0
Selcuk University
Country [1] 307109 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Scientific Research Projects Coordination Unit, Selcuk University(Alaaddin Keykubat Campus) Ardiçli, Ismetpasa Cad, 42250 Selçuklu/Konya,
Country
Turkey
Secondary sponsor category [1] 307681 0
None
Name [1] 307681 0
Address [1] 307681 0
Country [1] 307681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307224 0
Selcuk University Medical Faculty Research Ethics Commitee
Ethics committee address [1] 307224 0
Ethics committee country [1] 307224 0
Turkey
Date submitted for ethics approval [1] 307224 0
22/07/2019
Approval date [1] 307224 0
10/10/2019
Ethics approval number [1] 307224 0
19
Ethics committee name [2] 307225 0
The instution of Turkish Drugs and Medical Device
Ethics committee address [2] 307225 0
Ethics committee country [2] 307225 0
Turkey
Date submitted for ethics approval [2] 307225 0
Approval date [2] 307225 0
23/10/2019
Ethics approval number [2] 307225 0
E.170248

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106466 0
Prof Inci Kara
Address 106466 0
Selcuk University Medical Faculty
Department of Anesthesiology and Reanimation
Ardiçli, Ismetpasa Cad, 42250
Alaaddin Keykubat Campus
Selcuklu/Konya
Country 106466 0
Turkey
Phone 106466 0
+90 505 483 1819
Fax 106466 0
Email 106466 0
[email protected]
Contact person for public queries
Name 106467 0
Cansu Ciftci
Address 106467 0
Selcuk University Medical Faculty
Department of Anesthesiology and Reanimation
Ardiçli, Ismetpasa Cad, 42250
Alaaddin Keykubat Campus
Selcuklu/Konya
Country 106467 0
Turkey
Phone 106467 0
+90 546 285 8493
Fax 106467 0
Email 106467 0
[email protected]
Contact person for scientific queries
Name 106468 0
Cansu Ciftci
Address 106468 0
Selcuk University Medical Faculty
Department of Anesthesiology and Reanimation
Ardiçli, Ismetpasa Cad, 42250
Alaaddin Keykubat Campus
Selcuklu/Konya
Country 106468 0
Turkey
Phone 106468 0
+90 546 285 8493
Fax 106468 0
Email 106468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
core temperature measures which collected preoperative, during the operation and later than operation will be shared. Also pain scores, shivering scores and agitation scores will be shared.
When will data be available (start and end dates)?
All datas will be available immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Data will be available for any purpose.
How or where can data be obtained?
access subject to approvals by Principal Investigator([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.