Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
This study is currently recruiting participants.
Verified May 2012 by Massachusetts Eye and Ear Infirmary
Sponsor:
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01605903
First received: May 23, 2012
Last updated: May 24, 2012
Last verified: May 2012
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Purpose
Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Tonsillectomy Adenoidectomy |
Drug: Ibuprofen Drug: Acetaminophen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy |
Resource links provided by NLM:
Further study details as provided by Massachusetts Eye and Ear Infirmary:
Primary Outcome Measures:
- Level 3 postoperative hemorrhage [ Time Frame: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period. ] [ Designated as safety issue: Yes ]Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.
| Estimated Enrollment: | 1066 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment with Ibuprofen
Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
|
Drug: Ibuprofen
Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
|
|
Active Comparator: Treatment with Acetaminophen
Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6.
|
Drug: Acetaminophen
During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
- Patients with complex medical conditions and craniofacial abnormalities will be included.
- Informed consent and child assent will be required for enrollment
Exclusion Criteria:
- Patients with a known personal or family history of a bleeding disorder will be excluded.
- Patients with a history of asthma, kidney or liver problems will also be excluded.
- Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
- Patients on NSAIDs for other medical conditions, or those who have taken NSAIDs within 1 week of surgery will be excluded.
- Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
- Pregnancy testing using urine beta-HCG will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston. Patients found to be pregnant will be excluded from participation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605903
Contacts
| Contact: Christopner J Hartnick, MD | 617-572-4206 | christopher_hartnick@meei.harvard.edu |
| Contact: Gillian Diercks, MD | gillian_diercks@meei.harvard.edu |
Locations
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Christopher M Hartnick, MD 617-573-4206 christopher_hartnick@meei.harvard.edu | |
| Contact: Gillian Diercks, MD gillian_diercks@meei.harvard.edu | |
| Principal Investigator: Christopher Hartnick, MD | |
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
| Principal Investigator: | Christopher J Hartnick, MD | Massachusetts Eye and Ear Infirmary |
More Information
Publications:
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT01605903 History of Changes |
| Other Study ID Numbers: | 11-054H |
| Study First Received: | May 23, 2012 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts Eye and Ear Infirmary:
|
Tonsillectomy adenoidectomy bleeding bleeding rates Tonsillectomy with and without adenoidectomy |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Acetaminophen Ibuprofen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012
