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Trial record 9 of 463 for:    KETOROLAC

Effect of Ketorolac on Post Adenotonsillectomy Pain

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ClinicalTrials.gov Identifier: NCT03467750
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Gilbertson, Emory University

Brief Summary:
This randomized prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with obstructive sleep apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study group where they will receive ketorolac in addition to the standard of care treatment or will receive only the standard of care pain management. The researchers hypothesize that by administering ketorolac at the end of the procedure once hemostasis has been achieved, it will be possible to decrease the amount of morphine administered in the post-anesthesia care unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy and safety of the current standard post-operative analgesic regimen employed at the study institution, in which opioid analgesia currently plays a prominent role.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Ketorolac Drug: Standard of Care Phase 4

Detailed Description:

Obstructive sleep apnea (OSA) as an indication for adenotonsillectomy has increased significantly over the past ten years, and now has surpassed recurrent tonsillitis as the most common indication for this procedure. Opioids continue to be the most commonly administered pain medication for these procedures. Studies have shown that patients with OSA have significantly increased sensitivity to opioids that results in post-operative respiratory depression and apnea when administered via standard opioid dosing protocols. Children with OSA were shown to have a nearly fivefold increase in the odds of developing respiratory complications when compared to their counterparts with tonsillitis. Ketorolac possesses similar efficacy to morphine without the problematic complications of respiratory depression, nausea and vomiting, which are commonly seen post-adenotonsillectomy. Importantly, when combined with opioids, ketorolac is opioid-sparing. This synergistic effect means that a similar level of analgesia is achieved using a lower dose of opioid. However, there continues to be concern about using ketorolac due to the potential risk of post-operative bleeding from anti-platelet activity.

This randomized, prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with OSA undergoing adenotonsillectomy. Participants will be randomly assigned to receive ketorolac or to not receive ketorolac. The post-anesthesia care unit (PACU) nurses, who will be blinded to ketorolac administration, will evaluate the patients using the Face, Legs, Activity, Cry, Consolability (FLACC) scale scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. For patients with a FLACC score of 6-10, morphine (0.05mg/kg) will be administered. For patients with FLACC scores of 3-5, morphine (0.025mg/kg) will be administered. The total amount of opioid required to obtain a FLACC score of less than 3 will be evaluated as the primary outcome. The secondary outcomes to be evaluated will be PACU FLACC scores, time required in PACU, incidence of post-tonsillectomy bleeding and total pain medications administered during hospital admission.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: The PACU nurses will be blinded to ketorolac administration, but will be informed of all other medications given. The PACU nurses will evaluate the patients using FLACC scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. Morphine will be administered to obtain a FLACC score of less than 3.
Primary Purpose: Supportive Care
Official Title: Ketorolac as a Strategy for Reducing Post-operative Opioid Requirements in Children With Obstructive Sleep Apnea Undergoing Adenotonsillectomy: a Randomized Controlled Trial
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : August 24, 2020
Estimated Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Ketorolac
Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved
Drug: Ketorolac
Patients in this group will receive 0.5mg/kg of ketorolac, administered intravenously.
Other Name: Toradol

Drug: Standard of Care

All patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given.

A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure.

The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered.

Other Names:
  • Sojourn
  • Ultane
  • Diprivan
  • Decadron
  • Precedex
  • Zofran
  • Morphine

Active Comparator: Standard of Care
Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure.
Drug: Standard of Care

All patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given.

A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure.

The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered.

Other Names:
  • Sojourn
  • Ultane
  • Diprivan
  • Decadron
  • Precedex
  • Zofran
  • Morphine




Primary Outcome Measures :
  1. Post-Anesthesia Care Unit (PACU) Morphine Requirements [ Time Frame: Until PACU discharge (typically within 3 hours) ]
    The total postoperative morphine dosage required to achieve analgesia (defined as a Face, Legs, Activity, Cry, Consolability (FLACC) Scale score of less than 3) in children with obstructive sleep apnea undergoing adenotonsillectomy will be compared between study arms to examine the effect of ketorolac administration.


Secondary Outcome Measures :
  1. Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score [ Time Frame: 10 minutes post-op, 20 minutes post-op, PACU discharge (typically within 3 hours) ]
    Post-Anesthesia Care Unit (PACU) nurses will evaluate the patients using Face, Legs, Activity, Cry, Consolability (FLACC) Scale scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. Each category is scored as 0 (no indication of pain), 1 (indication of moderate pain), or 2 (visibly experiencing severe pain). Total scores range from 0 to 10, with higher scores indicating more pain.

  2. Post-Anesthesia Care Unit (PACU) Recovery Time [ Time Frame: Until PACU discharge (typically within 3 hours) ]
    The duration of time that a participant is in the Post-Anesthesia Care Unit (PACU), following surgery, measured in minutes.

  3. Incidence of Post-Tonsillectomy Bleeding [ Time Frame: Until complete recovery (typically within 7 days after surgery) ]
    Participants will be monitored for post-tonsillectomy bleeding. Post-surgical bleeding typically occurs within 7 days.

  4. Pain Medication Administration [ Time Frame: Surgery through hospital discharge (typically within 2 days) ]
    The total amount of pain medications administered during hospitalization will be examined.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of sleep disordered breathing or obstructive sleep apnea
  • Children undergoing elective tonsillectomy or adenotonsillectomy at Children's Healthcare of Atlanta Egleston location
  • Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Exclusion Criteria:

  • Known coagulation defect
  • Patients on longstanding NSAID therapy
  • Known renal impairment
  • Patients may also be excluded at the discretion of the investigator

Information from the National Library of Medicine

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): NCT03467750


Contacts
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Contact: Eric Hoar 404-785-1376 eric.hoar@choa.org
Contact: Laura Gilbertson, MD laura.gilbertson@emory.edu

Locations
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United States, Georgia
Childrens Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Eric Hoar    404-785-1376    eric.hoar@choa.org   
Sub-Investigator: Julie Schuman, MD         
Principal Investigator: Laura Gilbertson, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Laura Gilbertson, MD Emory University

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Responsible Party: Laura Gilbertson, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03467750     History of Changes
Other Study ID Numbers: IRB00097738
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laura Gilbertson, Emory University:
Adenotonsillectomy
Opioids
Post-surgical pain
Anesthesiology
Pediatrics

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action