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Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Adenotonsillectomy Patients

NCT06694077 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-19

No results posted yet for this study

Summary

This study explores the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain relief in children undergoing adenotonsillectomy. The procedure, often performed to address recurrent infections and airway obstruction, results in significant pain due to inflammation and nerve irtypicallyritation. Traditional pain management methods, such as systemic analgesics, may be inadequate or lead to side effects in children. By combining dexamethasone, a potent anti-inflammatory, with local anesthetics, this trial aims to determine if enhanced pain control and a reduction in opioid use can be achieved.

The randomized, double-blind clinical trial will involve 80 children aged 3 to 10 years, randomized into two groups: one receiving the nerve block with bupivacaine and dexamethasone, and the other receiving bupivacaine alone. Pain will be assessed postoperatively using the FLACC score, with secondary measures including time to first analgesia, total analgesic use, hemodynamic stability, and any complications.

This study aims to demonstrate that the addition of dexamethasone may provide superior pain management in pediatric adenotonsillectomy, offering a safer, opioid-sparing alternative for postoperative care.

Conditions

  • Tonsillectomy Postoperative Adverse Events
  • Dexamethasone Administration
  • Bupivacaine

Interventions

DRUG

Bupivacaine with Dexamethasone

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline.

DRUG

Bupivacaine only

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-04-01
Completion
2026-06-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694077 on ClinicalTrials.gov