Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001167358
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
8/08/2017
Date last updated
8/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Levobupivacaine and Levobupivacaine+Adrenalin in Pediatric Tonsillectomy Operations.
Scientific title
Comparison of The Perioperative and Postoperative Effects of Levobupivacaine and of Levobupivacaine+Adrenaline in Pediatric Tonsillectomy: A Double-Blind Randomized Study
Secondary ID [1] 292253 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tonsillitis 303763 0
Condition category
Condition code
Oral and Gastrointestinal 303131 303131 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 303648 303648 0 0
Other surgery
Anaesthesiology 303649 303649 0 0
Pain management
Infection 303650 303650 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 90 American Society of Anaesthesiologists class 1 or 2 (ASA I-II) patients between the ages of five and twelve participated in the study. After anaesthetic induction and before the operation, the patients were divided into groups. Levobupivacaine only (0.5%) 0.4 mg.kg-1 for group L (n=45), levobupivacaine (0.5%) 0.4 mg.kg-1+adrenaline (1:200.000) for group LA (n=45) were prepared for each tonsillar fossae. For each tonsillar fossae, 2.5 ml of the solution was injected as a withering and swollening submucosal infiltration in sterile conditions to the inferior and superior poles and to all areas surrounding the plicae of both tonsillar fossae by the otolaryngologist, who did not know which group was receiving which treatment. Anaesthesia was maintained by using 50% O2+ 50% N2O and 2% sevoflurane. The period between the placement of the mouth retractor for the operation and the removal of the mouth retractor after bleeding was controlled was recorded as the duration of the surgery. The perioperative amount of bleeding was deduced by measuring the aspirator apparatus and the swabs used and calculating the weight of the physiological saline solution before and after the operation. Cautery and suture use for the patients also were recorded. The patients were monitored in the postanesthesia care unit (PACU) postoperatively. The parents were taken into the PACU to decrease postoperative anxieties that the children might feel because they were in an unfamiliar environment. If present, diplopia, hallucination, cough, facial paralysis, vocal cord paralysis, bronchospasm, and postoperative bleeding were recorded as postoperative complications. At the end of the operation, the follow-up was taken over by an anaesthesiologist who did not know the study groups. In this way, the double-blind study protocol was maintained. Postoperatively, at the 10th, 30th, and 60th minutes and the 6th, 12th, and 24th hours, the pain scores of the patients were assessed by using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS), and nausea and vomiting were assessed by measuring postoperative nausea and vomiting (PONV:0 = no nausea or vomiting; 1= nausea but no vomiting; 2 = vomited once in 30 minutes; 3 = two or more episodes in 30 minutes). The modified Aldrete score (MAS) was used as a recovery criterion, and a MAS greater than 8 was considered to indicate recovery. For patients with a CHEOPS score greater than 6, pain treatment was conducted with intravenous asetaminofen within the first 6 hours and oral asetaminofen after the first 6 hours at a dose of 10 mg.kg.h-1. The time to the first analgesic request and the total amount of analgesic administered were recorded. If the PONV score was higher than 3, patients were treated with 150 µg.kg-1 of metoclopramide intravenously.
Intervention code [1] 298418 0
Treatment: Drugs
Intervention code [2] 298419 0
Prevention
Comparator / control treatment
Levobupivacaine
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302510 0
levobupivacaine and of levobupivacaine + adrenaline administered during tonsillectomy on postoperative pain
Timepoint [1] 302510 0
Postoperatively, at the 10th, 30th, and 60th minutes and the 6th, 12th, and 24thhours, the pain scores of the patients were assessed by using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS),
Secondary outcome [1] 336262 0
Secondary outcomes included (postoperative nausea and vomiting (PONV) were assessed by measuring postoperative nausea and vomiting (PONV:0 = no nausea or vomiting; 1= nausea but no vomiting; 2 = vomited once in 30 minutes; 3 = two or more episodes in 30 minutes).
Timepoint [1] 336262 0
At the 10th, 30th, and 60th minutes and the 6th, 12th, and 24th hours, the pain scores of the patients were assessed by using PONV.

Eligibility
Key inclusion criteria
Scheduled patients between the ages of five and twelve for pediatrictonsillectomy.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
. Patients who were known to be allergic to the drugs used in the study; patients with bleeding disorders or liver, kidney, cardiac, or lung diseases; patients more than 35 kg (potentially obese or having sleep apnea); patients who used antiemetics, analgesics, steroids, or antihistamines 24 hours before the operation; patients for whom the drugs used in the study were contraindicated; patients who returned for treatment of bleeding or any other complication after the operation; or patients whose parents did not consent to their participation in the study were excluded.

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
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
30/10/2015
Date of last data collection
Anticipated
Actual
31/10/2015
Sample size
Target
88
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 9008 0
Turkey
State/province [1] 9008 0
Konya

Funding & Sponsors
Funding source category [1] 296799 0
University
Name [1] 296799 0
Selcuk University Medical Faculty
Country [1] 296799 0
Turkey
Primary sponsor type
University
Name
Selcuk University Medical Faculty
Address
Akademi Mahallesi, 42130, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya
Country
Turkey
Secondary sponsor category [1] 296001 0
None
Name [1] 296001 0
Address [1] 296001 0
Country [1] 296001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298034 0
Selcuk University, Department of Medical Ethics
Ethics committee address [1] 298034 0
Ethics committee country [1] 298034 0
Turkey
Date submitted for ethics approval [1] 298034 0
04/03/2015
Approval date [1] 298034 0
23/04/2015
Ethics approval number [1] 298034 0
2015/9

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

Contacts
Principal investigator
Name 75766 0
A/Prof Faruk Cicekci
Address 75766 0
Selcuk Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon A.D..
Akademi Mahallesi, 42130, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya
Country 75766 0
Turkey
Phone 75766 0
+905057649235
Fax 75766 0
Email 75766 0
[email protected]
Contact person for public queries
Name 75767 0
Jale Bengi Celik
Address 75767 0
Selcuk Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon A.D..
Akademi Mahallesi, 42130, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya
Country 75767 0
Turkey
Phone 75767 0
+905335656838
Fax 75767 0
Email 75767 0
[email protected]
Contact person for scientific queries
Name 75768 0
Jale Bengi Celik
Address 75768 0
Selcuk Üniversitesi Tip Fakültesi Anesteziyoloji ve Reanimasyon A.D..
Akademi Mahallesi, 42130, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya
Country 75768 0
Turkey
Phone 75768 0
+905335656838
Fax 75768 0
Email 75768 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseComparison of the Perioperative and Postoperative Effects of Levobupivacaine and of Levobupivacaine + Adrenaline in Pediatric Tonsillectomy: A Double-Blind Randomized Study.2017https://dx.doi.org/10.1155/2017/8431823
N.B. These documents automatically identified may not have been verified by the study sponsor.