Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
35 participants
INTERVENTIONAL
2020-07-22
2023-08-22
Brief Summary
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Detailed Description
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Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy.
Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy.
Study Design: Prospective, randomized, multi-center trial study
Study Interventions and Measures:
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group
The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Blinded members include the subject/family members, the surgeon, staff who perform post-op assessment, physician investigator who perform any adverse event/serious adverse event (AE/SAE) assessments, statistician and data safety monitoring board (DSMB).
Study Groups
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Traditional Care Group (TCG)
Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding.
Morphine
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Fentanyl
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Opioid-Free Group (OFG)
Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.
Ketorolac
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Dexmedetomidine
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Interventions
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Ketorolac
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Dexmedetomidine
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Morphine
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Fentanyl
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
3. Girls after menarche must have a negative pregnancy test.
4. Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers.
5. Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria
2. High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
3. Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
4. History of drug abuse, chronic pain, bleeding disorder
5. Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
6. Significant congenital disorders, medication allergies or comorbidities, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease and use of medications that would increase risk of bleeding or bradycardia.
7. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
8. History of hypersensitivity to NSAIDs
9. Patients with asthma, including patients who have experienced aspirin- or NSAID-sensitive asthma or a history of exacerbation when aspirin or NSAIDs are administered (e.g. bronchospasm, urticaria, etc.)
10. Subjects receiving medications that could impact metabolism of either study drug should also be excluded
11. Trisomy 21 diagnosis
12. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
13. Patients on a Ketogenic diet
14. Parents or subjects who do not speak English
2 Years
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
University of Tennessee
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Tori Sutherland, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Anthony Sheyn, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center; St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044). Center f
Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial.
Buck, ML. Use of Intravenous Ketorolac for Postoperative Analgesia in Infants: Pediatric Pharmacotherapy, A Monthly Newsletter. . 2011
Other Identifiers
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19-016618
Identifier Type: -
Identifier Source: org_study_id