A Phase 4 interventional study of Bupivacaine with Dexamethasone and Bupivacaine only in Tonsillectomy Postoperative Adverse Events, Dexamethasone Administration and Bupivacaine, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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.
This study is about the Analgesic Effect of Suprazygomatic Maxillary Nerve Block with and without Dexamethasone in Pediatric Adenotonsillectomy: A Randomized Double-Blinded Clinical Trial," investigates the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain management in children undergoing adenotonsillectomy. Adenotonsillectomy, a frequent surgical procedure in pediatric patients to address chronic infections and airway obstruction, is commonly associated with significant postoperative pain due to thermal and mechanical injury to tissues. This injury triggers inflammation, muscle spasms, and nerve irritation, which can lead to severe discomfort, decreased oral intake, and potential complications like dehydration.
The tonsils are primarily innervated by the maxillary division of the trigeminal nerve and the glossopharyngeal nerve, while the adenoids are innervated by branches of the trigeminal nerve alone. Despite traditional systemic analgesics being standard in pain management for such cases, they may not always provide adequate relief and can introduce undesirable side effects, particularly in pediatric patients. This limitation has spurred interest in regional anesthesia techniques, such as the suprazygomatic maxillary nerve block, which has been used in various facial and dental procedures but is less common in adenotonsillectomy. Combining dexamethasone, a potent corticosteroid known for its anti-inflammatory properties, with local anesthetics could provide enhanced analgesia and prolong the block's duration, potentially reducing the need for additional opioids post-surgery.
This randomized, double-blind, controlled clinical trial will be conducted at the ENT Operating Theatre at Assiut University Hospitals. The study will involve 80 pediatric patients between 3 and 10 years old, classified as ASA physical status I or II, who are scheduled for adenotonsillectomy. Participants will be randomized into two groups of 40 each: Group A will receive a suprazygomatic maxillary nerve block with 0.5% bupivacaine combined with dexamethasone, and Group B will receive the same nerve block with bupivacaine alone.
For statistical analysis, data will be verified, coded, and processed using IBM-SPSS 24.0 software. Mean and standard ddeviations will be calculated for normally distributed variables, and a two-way repeated measures ANOVA will be used to analyze pain score trends over time. A significance level of p\<0.05 will be used for all analyses.
Ultimately, this study aims to establish whether adding dexamethasone to the suprazygomatic maxillary nerve block could enhance pain control, reduce the need for systemic analgesics, and improve overall recovery outcomes for pediatric patients undergoing adenotonsillectomy. Positive findings may position this combination as a safer, more effective pain management strategy, potentially improving the postoperative experience and outcomes in pediatric surgeries
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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 with Dexamethasone
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
Drug: Bupivacaine only
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.
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
the total amount of analgesic requirements during first the 24hr after two different blocks.
Time frame: Postoperative 24 hours
Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC)
Time frame: 1hour , 2hour, 6hour, 12hour, 24hour
No study locations are listed for this record.
Plan to share: No
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Assiut University