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

• Status: Terminated
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of combining two interventions already in use at some institutions for reducing post-operative pain following tonsillectomy or adenotonsillectomy. The standard of care at most institutions is to leave the tonsillectomy wound bed exposed to heal on its own over one to two weeks. At many institutions, surgeons inject or topically apply local anesthetics such as bupivacaine hydrochloride to the tonsillectomy wound bed to help reduce post-operative pain. At other institutions, surgeons apply a layer of fibrin sealant, which is derived from the proteins that help form blood clots in blood, to the tonsillectomy wound bed in order to cover the site and reduce irritation and exposure of the wound bed. Use of fibrin sealant has the additional benefit of potentially reducing postoperative bleeding (hemorrhage) rates. Both the post-tonsillectomy use of bupivacaine (injection and topical) and the use of topical fibrin sealant application have been studied previously in the scientific literature; some studies show a clear benefit, others show no significant reduction in pain when they are used. No studies have documented harm. The purpose of this study is to evaluate the efficacy of infusing bupivacaine anesthetic into the fibrin sealant prior to application to the tonsillectomy wound bed. In this way, the combined product would function as a sort of "medicated bandaid" covering the painful wound bed and slowly delivering an entirely safe total dose of bupivacaine into the wound bed to reduce post-operative pain. Parents will be provided post-operative pain measurements to complete during the first 10 postoperative days and return to the researchers for data analysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University School of Medicine
• Treatments: Bupivacaine; Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

1. All children aged 1 through age 12 and weighing >10 kilograms who are scheduled for tonsillectomy or adenotonsillectomy for the following indications by surgical staff included in the IRB submission will be considered for inclusion in the study.

A) Chronic Pharyngitis / Recurrent Tonsillitis B) PAPFA (Periodic Aphthous Ulcers / Pharyngitis / Fevers / Adenopathy) Syndrome C) Upper Aerodigestive Obstruction Symptoms felt to be related to tonsil size. D) Adenotonsillar Hypertrophy (enlarged tonsils and adenoids) E) Obstructive Sleep Apnea (clinical diagnosis or by Polysomnogram [sleep study]) F) Chronic/Recurrent Tonsillolithiasis (tonsil stones)

Exclusion Criteria:

1. Undergoing additional surgical procedures within 14 days preceding or following the tonsillectomy or adenotonsillectomy which could affect pain assessment scores.

2. Additional concurrent surgical procedures (other than direct laryngoscopy, bronchoscopy, nasal endoscopy, ear examination under anesthesia, cerumen removal, or myringotomy with ear ventilation tube placement)

2. If decision is made to perform supraglottoplasty for laryngomalacia intraoperatively

3. Tonsillectomy or adenotonsillectomy for concern of malignancy of unknown primary

4. Documented aprotinin allergy

5. Documented amide anesthetic allergy

6. Documented bleeding disorder

7. Documented anticoagulant use

8. Documented chronic pain disorder

9. Documented chronic use of prescription narcotics or methadone

10. Documented history of substance abuse or illicit drug use

11. Documented history of alcoholism or alcohol abuse

12. Gastrostomy/orogastric/nasogastric tube placement/use

13. Planned postoperative ICU placement

14. Refusal to participate

15. Exclusion at judgment of investigator (Language barriers, Ward of Court, etc.)