UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044181 |
|---|---|
| Receipt number | R000050451 |
| Scientific Title | Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2021/05/12 |
| Last modified on | 2021/05/12 05:50:56 |
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Basic information
Public title
Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Acronym
Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title
Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial
Region
| Japan |
Condition
Condition
tonsillectomy
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the analgesic effect of ultrasound-guided maxillary nerve block in pediatric patients undergoing palatine tonsillectomy and adenoidectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
FLACC scores immediately after surgery, 2 hours, 4 hours, and 24 hours after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ultrasound-guided maxillary nerve block will be performed and 0.2% ropivacaine will be administered.
Consent will be obtained from the patients and their guardians on the day before surgery, and the groups will be randomly assigned. On the day of surgery, midazolam syrup 0.5 mg/kg will be administered 30 minutes before entering the operating room. After entering the operating room, general anesthesia will be induced. Maxillary nerve block with a local anesthetic (0.2% ropivacaine) at a dose of 0.15 mL/kg or local injection of saline at a dose of 0.15 mL/kg is performed according to the allocation on the previous day. As in conventional pain management methods, saline injection by the surgeon is performed immediately before the procedure. The amount of narcotic analgesics used intraoperatively and pain assessment immediately after awakening from anesthesia, at 2 hours, and at 4 hours will be performed. Postoperatively, the patient should be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring tracheal intubation or ventilatory management. From the day after surgery onward, in addition to the usual postoperative rounds, pain assessment should be performed at 24 hours. The patient will be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring intubation or ventilatory management until 24 hours after surgery.
Interventions/Control_2
Ultrasound-guided maxillary nerve block will be performed and saline will be administered.
Consent will be obtained from the patients and their guardians on the day before surgery, and the groups will be randomly assigned. On the day of surgery, midazolam syrup 0.5 mg/kg will be administered 30 minutes before entering the operating room. After entering the operating room, general anesthesia will be induced. Maxillary nerve block with a local anesthetic (0.2% ropivacaine) at a dose of 0.15 mL/kg or local injection of saline at a dose of 0.15 mL/kg is performed according to the allocation on the previous day. As in conventional pain management methods, saline injection by the surgeon is performed immediately before the procedure. The amount of narcotic analgesics used intraoperatively and pain assessment immediately after awakening from anesthesia, at 2 hours, and at 4 hours will be performed. Postoperatively, the patient should be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring tracheal intubation or ventilatory management. From the day after surgery onward, in addition to the usual postoperative rounds, pain assessment should be performed at 24 hours. The patient will be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring intubation or ventilatory management until 24 hours after surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Target patients: Pediatric patients undergoing palatine tonsillectomy and adenoidectomy under general anesthesia
Age range: 3-7 years
Selection criteria
Pediatric patients who will undergo palatine tonsillectomy only
Pediatric patients undergoing palatine tonsillectomy and adenoidectomy
Key exclusion criteria
Patients who are allergic to ropivacaine
Patients who have an anatomical abnormality in the area where maxillary nerve block is performed.
Patients who are judged by the anesthesiologist in charge, the principal investigator, or the sub-investigator to be inappropriate for participation in this study.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesioogy
Zip code
060-8543
Address
S1W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-688-9663
chakitomohiro0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kumita |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-688-9663
Homepage URL
todonotumari@me.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Institutional Review Board
Address
S1W16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
todonotumari@me.com
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1011210004
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050451
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| Registered date | File name |
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