Analgesic Adverse Reaction Clinical Trial
Official title:
A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
This prospective, randomized, double blinded study is designed to compare the bleeding rates of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients ages 2-18.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: -ASA physical status I to III, age of 2 years to 18 years old (inclusive) scheduled for elective tonsillectomy with or without adenoidectomy. Exclusion Criteria: -Exclusion criteria are: allergy to any nonsteroidal anti-inflammatory medications, bleeding disorders, history of gastrointestinal bleeding, renal impairment, severe asthma, cardiac/hepatic disease, use of anticoagulation, recent NSAID use (within last 72 hours) or any other medical problem that in the opinion of investigator would interfere with study participation. |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
Lead Sponsor | Collaborator |
---|---|
Albany Medical College |
United States,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rebleeding rate requiring operative intervention | Rebleeding rate requiring operative intervention measured by recording either yes or no the patient did or did not returned to the OR for bleeding related to recent tonsillectomy. Requiring operative intervention would be a worse outcome than not requiring operative intervention. | 2 weeks post-operative | |
Secondary | PACU length of stay | PACU length of stay in minutes from admission to discharge. The longer the length of PACU stay the worse the outcome. | Immediately after operation | |
Secondary | Post-operative opioid dosage | Post- operative opioid requirement in mg of Morphine/ Morphine equivalent. The greater the amount of opioid used the worse the outcome. | Immediately after operation | |
Secondary | Post-operative pain score | Pain scores ranging from 0 to 5 will be collected using the Visual Analogue Pain. scale. A score of 0 indicates no pain and a score of 5 indicates unbearable pain. The greater the pain score would indicate a worse outcome. | Immediately after operation | |
Secondary | Presence of post-operative nausea/vomiting | The presence of post operative nausea or vomiting while in the PACA measured by either yes or no. The presence of pots-operative nausea or vomiting would indicate a worse outcome. | Immediately after operation | |
Secondary | Number of emergency room visits/admissions | The number of actual emergency room visits by the patient measured numerically from 1 to infinity. The greater the number of emergency room visits would indicate a worse outcome. | 2 weeks post-operative |
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