patients who will undergo an endoscopy through g-tube port

Esophagogastroduodenoscopies

Placement the endoscope through the g-tube port and not through the mouth of a patient undergoing an upper gi endoscopy

transgastrostomal endoscopy

Yale University

Transgastrostomal Endoscopies

Efficacy of Transgastrostomal Esophagogastroduodenoscopies in Children

Conduct a full endoscopy via g-tube port. Advance the scope to all standard locations including proximal esophagus, distal esophagus, stomach, duodenal bulb and the second part of the duodenum. Obtain at least 2 specimens from each location.

Assess the rate of anesthesia related adverse reactions. Specifically, record the number of oxygen desaturations during the endoscopy (vital signs are continuously recorded during the exam). After the procedure the anesthesia team will summarize any anesthesia adverse reactions that have occurred during the exam.

To examine the efficacy of transgastrostomal endoscopies among a single group of patients with a gastrostomy feeding tube

44 patients will be randomized to receive no topical treatment to their tonsillectomy (or adenotonsillectomy) wound bed as is the current standard of care at our institution. The wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis alone.

44 patients will be randomized to receive application of topical fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.

44 patients will be randomized to receive application of topical bupivacaine-infused fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.

Control

44 patients will be randomized to receive application of topical fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.
Fibrin Sealant: Fibrin sealant will be applied to the wound bed topically as per product instructions.

Fibrin Sealant Alone

44 patients will be randomized to receive application of topical bupivacaine-infused fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis.
Bupivacaine: 1 milliliter (mL) of 0.75% Bupivacaine Hydrochloride will be infused into 4mL of fibrin sealant (diluting the Bupivacaine HCl to 0.15%). The bupivacaine-infused fibrin sealant will then be applied to the tonsillectomy (or adenotonsillectomy) wound bed.

Bupivacaine-infused Fibrin Sealant

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

study closed for administrative reasons

Tonsillectomy (and adenotonsillectomy) are associated with a 3-5% postoperative hemorrhage risk from the tonsillectomy wound beds across the United States; our institution has a calculated average of between 4% - 5%. Parents will be contacted 2 to 3 weeks following their procedure and inquiries about post-operative bleeding will be made. Bleeding >1 tablespoon or that requires A) presentation to an emergency department, B) admission to a hospital, or C) return to the operating room will be considered significant post-operative hemorrhage. Distinction will also be made between early (<24 hours after surgery) and late (>24 hours after surgery) postoperative bleeding. The bleeding risk after 2 weeks from surgery is exceedingly small. No prior studies have identified any increased risk with utilizing either fibrin sealant or bupivacaine. This study will evaluate whether the intervention reduces bleeding risk.

study terminated due to FDA requirement for a investigational new drug application requirement. Subjects did not receive Fibrin sealant nor Bupivacaine

Control Arm

subjects received fibrin sealant to tonsillar fossa

subjects received Bupivacaine-infused Fibrin Sealant to tonsillar fossa

Postoperative Hemorrhage; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement

Parents/caregivers will be asked to perform thrice daily pain assessments utilizing a validated postoperative pain measurement scale for the 10 days after surgery. study terminated due to FDA requirement for a investigational new drug application requirement

subjects did not receive fibrin sealant nor bupivacaine

Postoperative Pain; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement

The postoperative pain assessment sheets will contain a daily entry for the estimated total doses of pain medication required and will distinguish between the need for narcotic and non-narcotic pain medication requirements.

Control Arm did not receive any Fibrin sealant nor Bupivacaine

Fibrin Sealant Alone- subjects received only fibrin sealant to tonsillar fossa

Bupivacaine-infused Fibrin Sealant was placed in tonsillar fossa of subjects

Total Pain Medication Usage

The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal diet.

Time to Return to Normal Diet

The postoperative pain assessment sheets will contain a daily entry for the estimated number of required calls to the clinic or to the physician on call overnight.

Number of Required Calls to Healthcare Personnel (Either the Clinic or the Physician on Call Overnight)

The postoperative pain assessment sheets will contain a daily entry for the estimated number of episodes of vomiting the patient experienced.

Postoperative Nausea & Emesis

The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal activity level.

Time to Return to Normal Activity

Overall Study

Bruce H. Matt, MD, MSc

subjects did not receive Fibrin sealant nor bupivacaine

subjects received fibrin sealant alone to the tonsillar fossa

subjects received Bupivacaine-infused Fibrin Sealant to the tonsillar fossa

Pain, Postoperative

Postoperative Hemorrhage

1 milliliter (mL) of 0.75% Bupivacaine Hydrochloride will be infused into 4mL of fibrin sealant (diluting the Bupivacaine HCl to 0.15%). The bupivacaine-infused fibrin sealant will then be applied to the tonsillectomy (or adenotonsillectomy) wound bed.

Bupivacaine

Fibrin sealant will be applied to the wound bed topically as per product instructions.

laryngomalacia/vomiting

Transgastrostomal Endoscopies

Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage

Laryngomalacia Exposed

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