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The effect of lidocaine spray on postoperative pain after pharyngeal flap surgery: A double-blind, randomized, controlled trial

The effect of lidocaine spray on postoperative pain after pharyngeal flap surgery: A double-blind, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056376
Enrollment
Unknown
Registered
2022-02-04
Start date
2022-01-28
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

postoperative analgesia

Interventions

Intervention group:lidocaine spray
Control group:Placebo

Sponsors

Department of Anesthesiology, Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 4 to 14 years old; 2. ASA I-II; 3. Velopharyngeal insufficiency, posterior pharyngeal flap surgery; 4. Enrolled in the study are all minor patients, and the guardian's consent is required to participate.

Exclusion criteria

Exclusion criteria: 1. Child has cognitive or neuropsychiatric diseases, and developmental delay; 2. Lidocaine and alcohol allergy; 3. Pharyngeal infection or suspected malignant tumor; 4. Have a history of asthma; 5. Long-term use of anticonvulsant, sedative and analgesic drugs; 6. Abnormal liver and kidney function; 7. Severe cardiovascular and cerebrovascular diseases, coagulation disorders; 8. Patients with severe sleep apnea (sleep apnea index>=5.0).

Design outcomes

Primary

MeasureTime frame
Compare the maximum pain scores of the two groups in patients during PACU;

Secondary

MeasureTime frame
The extubation time;Pain scores in different time periods of PACU (10min, 20min, 30min, 30min to exit PACU);The incidence of moderate to severe pain in PACU; The rescue opioids for PACU and 24 hours postoperatively, the time of first rescue ;Agitation score and incidence of delirium;Pain score for 24 hours ater surgery;The incidence of moderate to severe pain within 24 hours after leaving PACU;The rescue oral analgesics on the wards;The incidence of nausea and vomiting in PACU and wards;Time to resume eating;Postoperative hospital stay;Parent satisfaction (0-10 points);24h postoperative complications: respiratory complications (hypoxemia: blood oxygen saturation 30 seconds), bleeding, infection, secondary operations, etc.;

Countries

China

Contacts

Public ContactZhou Dan

Peking University Hospital of Stomatology

zhoudan2011@163.com+86 18613839301

Outcome results

None listed

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