Dexmedetomidine for Adenotonsillectomy
(SZMB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding dexmedetomidine, a sedative medication, to a pain relief method helps children recover without opioids after adenotonsillectomy, a surgery to remove tonsils and adenoids. Researchers seek to understand if combining dexmedetomidine with a local anesthetic reduces pain and enhances recovery at home. The trial compares three groups: one receiving both dexmedetomidine and a local anesthetic, one with only a local anesthetic, and one with dexmedetomidine administered through an IV. Children scheduled for a partial adenotonsillectomy and experiencing significant sleep-disordered breathing may qualify. As an unphased trial, this study provides a unique opportunity to advance understanding of new pain management strategies for children.
Will I have to stop taking my current medications?
The trial requires that participants not be on certain medications that affect the nervous system, like antimuscarinics, beta-2 adrenergic agonists, alpha-1 adrenergic antagonists, antiarrhythmic agents, or tricyclic antidepressants. If you are on these medications, you may need to stop taking them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In previous studies, dexmedetomidine has been shown to be safe for children. Research shows it helps manage issues like restlessness and confusion after surgery, which is particularly beneficial for children undergoing procedures such as tonsil removal. One study found that dexmedetomidine reduced post-surgery pain without causing major side effects. However, another study noted more minor side effects compared to a group not using the drug, though these were not serious. Overall, dexmedetomidine appears to be well-tolerated by children.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about using dexmedetomidine in adenotonsillectomy procedures because it offers a different approach to managing pain and sedation compared to standard treatments like opioids and general anesthesia. Dexmedetomidine is unique because it can provide sedation without respiratory depression, which is a common side effect of traditional sedatives and pain medications. Additionally, dexmedetomidine has analgesic properties, potentially reducing the need for other painkillers post-surgery. By combining dexmedetomidine with ropivacaine, a local anesthetic, the treatment aims to enhance pain control while minimizing systemic side effects. This could mean a more comfortable recovery for patients, with fewer complications.
What evidence suggests that this trial's treatments could be effective for adenotonsillectomy recovery?
This trial will compare different methods of administering dexmedetomidine for pain relief after adenotonsillectomy. Studies have shown that combining dexmedetomidine with ropivacaine can significantly improve pain relief after this common surgery to remove the tonsils and adenoids. In this trial, Group RD will receive a combination of dexmedetomidine and ropivacaine, which research indicates provides better pain relief than ropivacaine alone. Group D will receive dexmedetomidine through an IV, which has been found to help control pain and reduce restlessness in children after surgery. Overall, both the combination of dexmedetomidine with ropivacaine and dexmedetomidine given through an IV are believed to aid recovery by reducing pain and discomfort.678910
Are You a Good Fit for This Trial?
This trial is for children scheduled for elective partial adenotonsillectomy with a STUBR score ≥ 3, indicating significant sleep-disordered breathing. Participants must have parents fluent in French or English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Suprazygomatic Maxillary Nerve Block (SZMB) during surgery with different combinations of ropivacaine and dexmedetomidine
Immediate Postoperative Evaluation
Participants are evaluated after surgery for opioid consumption, pain severity, level of agitation, and level of delirium
Follow-up
Participants complete a daily questionnaire for 7 days after surgery on pain and recovery
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor