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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-10
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Parturient of American Society of Anesthesiologists (ASA) class I or II physical status

Children scheduled for tonsillectomy with adenoidectomy

Disqualifiers

Patient's guardian refusal to participate in the study. Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.

Children on sedative or anticonvulsant medication.

Bleeding diathesis

History of sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine with Dexamethasone

    Drug

    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.

  • Bupivacaine only

    Drug

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Bupivacaine with DexamethasoneExperimental treatment 1 intervention
Group B: Bupivacaine onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the total amount of analgesic requirements during first the 24hr after two different blocks.

Time frame
Postoperative 24 hours

Secondary outcomes

1

Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC)

Time frame
1hour , 2hour, 6hour, 12hour, 24hour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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