Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
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|ClinicalTrials.gov Identifier: NCT03453541|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Analgesic Adverse Reaction||Drug: Ketorolac Tromethamine Drug: 0.9% Normal Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||CRNAs, PACU nurses, and participants are all blinded|
|Official Title:||A Randomized, Double-blinded, Placebo-controlled Study of Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy|
|Actual Study Start Date :||November 21, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Ketorolac Tromethamine
This group receives Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Drug: Ketorolac Tromethamine
Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Other Name: Toradol
Placebo Comparator: 0.9% Normal Saline
This group will receive 0.9% Normal Saline solution 1ml/60kg up to 1ml IV bolus (an equivalent volume as per kg Ketorolac Tromethamine dose) at the completion of the tonsillectomy in the operating room.
Drug: 0.9% Normal Saline
0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.
Other Name: 0.9% Sodium Chloride
- Rebleeding rate requiring operative intervention [ Time Frame: 2 weeks post-operative ]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.
- PACU length of stay [ Time Frame: Immediately after operation ]PACU length of stay in minutes from admission to discharge. The longer the length of PACU stay the worse the outcome.
- Post-operative opioid dosage [ Time Frame: Immediately after operation ]Post- operative opioid requirement in mg of Morphine/ Morphine equivalent. The greater the amount of opioid used the worse the outcome.
- Post-operative pain score [ Time Frame: Immediately after operation ]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.
- Presence of post-operative nausea/vomiting [ Time Frame: Immediately after operation ]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.
- Number of emergency room visits/admissions [ Time Frame: 2 weeks post-operative ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453541
|Contact: Farzana Afroze, MD||518-262-3125||AfrozeF@amc.edu|
|Contact: Jason mouzakas, MD||518-262-4300|
|United States, New York|
|Albany Medical Center||Recruiting|
|Albany, New York, United States, 12208|
|Contact: Farzana Afroze, MD 518-262-3125 AfrozeF@amc.edu|
|Sub-Investigator: Eric P Zhou, MD|
|Sub-Investigator: Carolyn DeBiase, MD|
|Sub-Investigator: Melissa Ehlers, MD|
|Sub-Investigator: Sakina Rangwala, MD|
|Sub-Investigator: Jason Mouzakes, MD|
|Sub-Investigator: Patrick Savery, DO|
|Sub-Investigator: Anica Crnkovic, MD|
|Sub-Investigator: Helena Oechsner, MD|
|Sub-Investigator: Yarnell LaFortune, MD|
|Sub-Investigator: Igor Galay, MD|
|Sub-Investigator: : Pragnyadipta Mishra, MBBS|
|Principal Investigator:||Farzana Afroze, MD||Albany Medical College|