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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044181
Receipt No. 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

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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
Email 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
Email todonotumari@me.com

Sponsor
Institute Sapporo Medical University School of Medicine, Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050451

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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