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Effect of intraoperative lidocaine pumping on postoperative sleep in children undergoing bilateral tonsillectomy with adenoidectomy: a randomized, controlled, double-blind, prospective study

Effect of intraoperative lidocaine pumping on postoperative sleep in children undergoing bilateral tonsillectomy with adenoidectomy: a randomized, controlled, double-blind, prospective study - Effect of lidocaine on tonsillar adenoidectomy in pediatric patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080426
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tonsillar adenoidectomy

Interventions

Lidocaine group:Lidocaine was given 1.5 mg·kg-1 lidocaine at the time of anesthesia induction, followed by 2 mg·kg-1·h-1 pumping immediately until the end of the operation.
Blank control group:Conventional general anesthesia induction + equal volume normal saline + conventional anesthesia + intraoperative continuous pumping of equal volume normal saline until the end of

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1) 4 years old= age < 8 years old ; 2) Day surgery patients undergoing elective bilateral tonsillectomy with adenoidectomy; 3) ASA Class I or II; 4) Sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1) the patient refuses to participate; 2) ASA grade III and above; 3) history of local anesthetic allergy; 4) Previous mental illness such as anxiety and depression or sleep disorders; 5) Behavioral developmental disorders (such as hyperactivity-attention deficit disorder, learning difficulties) 6) severe heart block (including sinus, atrioventricular and ventricular block); 7) pre-excitation syndrome; 8) Are taking psychotropic drugs (such as psychostimulants, anticonvulsants, antihistamines, etc.) 9) Other cases deemed inappropriate in research.

Design outcomes

Primary

MeasureTime frame
CSHQ score;vital signs;FLACC scoring in resuscitation chambers;Pain at the surgical site VAS score;

Secondary

MeasureTime frame
Incidence of postoperative nausea and vomiting;After extubation, there is no choking cough and cough score from the PACU outlet;PACU dwell time;General information included age, sex, body mass index, and duration of surgery;

Countries

China

Contacts

Public ContactShangguan Wangning

Wenzhou Medical University Affiliated Stomatological Hospital

sgwning@163.com+86 135 8763 7891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026