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IV Acetaminophen and Post-Tonsillectomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03883893
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : July 24, 2019
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.

Condition or disease Intervention/treatment Phase
Tonsillectomy Adenoidectomy Drug: Intravenous acetaminophen Other: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.
Primary Purpose: Prevention
Official Title: Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: IV Tylenol
Participants will receive IV acetaminophen 15mg/kg in the OR.
Drug: Intravenous acetaminophen
Intravenous acetaminophen will be given in the OR.
Other Name: IV Tylenol

Placebo Comparator: Normal Saline
Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen.
Other: Normal saline
Normal saline will given if randomized to this group.

Primary Outcome Measures :
  1. Post-operative pain scores [ Time Frame: Every 5 minutes after awake in recovery room for 30 minutes ]
    FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain

Secondary Outcome Measures :
  1. Quality of emergence from anesthesia [ Time Frame: When first spontaneous eye movement occurs in recovery room ]

    Pediatric Anesthesia Emergence Delirium scale (PAED)

    This scale uses 5 criteria to determine the extent of emergence delirium in children. "The child makes eye contact with the caregiver", "The child's actions are purposeful", The child is aware of his/her surroundings", The child is restless" and "The child is inconsolable." Each of these 5 catagories are scored on a 0-4 scale. The higher the total number the greater the extent of the emergence delirium.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject is age 3 to 10 years (inclusive)
  2. The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
  3. The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
  4. The subject is ASA patient classification I-II
  5. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

  1. Additional surgical procedures are being performed concurrently;
  2. The subject is ASA classification > II;
  3. The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
  4. The subject receives midazolam as a premedication;
  5. The subject has a history of chronic malnutrition;
  6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study

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 identifier (NCT number): NCT03883893

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Contact: Judy Audas, APRN-CRNA,MSN 513-636-4408
Contact: Kristie Geisler, BS 513-636-3282

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Principal Investigator: Judy Audas, APRN-CRNA,MSN Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT03883893     History of Changes
Other Study ID Numbers: 2018-0565
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Intravenous Acetaminophen
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs