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SZMN Treatment Group for Opioid Use Disorder

N/A

Recruiting

Led By Stephanie Pan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 6 months - 18 years

Patients undergoing tonsillectomy and adenoidectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: 14 days after surgery

Awards & highlights

Study Summary

This trial aims to investigate if a nerve block called suprazygomatic maxillary nerve (SZMN) block can help reduce pain and complications in children undergoing tonsillectomy and adenoidectomy procedures

Who is the study for?

This trial is for children aged 6 months to 18 years who are undergoing tonsillectomy and adenoidectomy. They must have consent from themselves or a parent to participate.Check my eligibility

What is being tested?

The study tests if the SZMN block, a pain management technique, can help control pain after T&A surgery in kids. It also examines whether adding dexmedetomidine prolongs its pain-relieving effects.See study design

What are the potential side effects?

Possible side effects may include discomfort at the injection site, low blood pressure, slow heart rate due to dexmedetomidine, and typical risks associated with nerve blocks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 months and 18 years old.

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I am having my tonsils and adenoids removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: 14 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: 14 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: 14 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative Opioid Consumption

Postoperative Surgical Pain

Secondary outcome measures

Complications from block

Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SZMN+Dexmedetomidine Treatment GroupExperimental Treatment1 Intervention

Patients randomized into the SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic along with 0.25 mcg/kg (max 10 mcg) Dexmedetomidine on each side (total of 0.5 mcg/kg, total max 20 mcg).

Group II: SZMN Treatment GroupExperimental Treatment1 Intervention

Patients randomized into the SZMN treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic per side.

Group III: No Intervention: Control GroupActive Control1 Intervention

Patients in this group will receive the standard of care for T&A procedures within the pediatric population.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,365 Total Patients Enrolled

Stephanie Pan, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

26 Total Patients Enrolled

Ban CH Tsui, MDStudy DirectorStanford University

2 Previous Clinical Trials

160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for patients to enroll in this clinical trial?

"Indeed, information on clinicaltrials.gov confirms that recruitment is ongoing for this trial. The trial was initially listed on January 29th, 2024 and last amended on April 16th of the same year. A total of 90 individuals are being sought from a single site."

Answered by AI

Are individuals who are older than 30 years eligible to participate in this study?

"Participants must be between 6 months and 18 years old to qualify for enrollment in this investigation."

Answered by AI

What is the current number of participants enrolled in this clinical investigation?

"Yes, the details on clinicaltrials.gov reveal that this medical trial is actively soliciting participants. The initial posting date was 29th January 2024 and the most recent update was made on 16th April 2024. Enrollment of a total of 90 patients will take place at one single site."

Answered by AI

Recent research and studies

AnesthesiologyJournal

Bilateral Suprazygomatic Maxillary Nerve Block for Cleft Palate Repair in Children

Chiono, Julien, Olivier Raux, Sophie Bringuier, Chrystelle Sola, Michèle Bigorre, Xavier Capdevila, and Christophe Dadure. 2014. “Bilateral Suprazygomatic Maxillary Nerve Block for Cleft Palate Repair in Children”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000000171.

clinicaltrials.govStudy

Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control

Stephanie Jiaying Pan 2024. "Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208892.