Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage
Condition: Pain, Postoperative; Postoperative Hemorrhage
MeSH terms: Hemorrhage; Pain, Postoperative; Postoperative Hemorrhage
Intervention: Bupivacaine; Fibrin Sealant
Intervention description: 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.; Fibrin sealant will be applied to the wound bed topically as per product instructions.
Intervention MeSH terms: Bupivacaine; Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tonsillectomy; Adenotonsillectomy; Pain; Hemorrhage

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.
    

Eligibility 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.)