Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Acetaminophen in Posterior Fossa Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02532322
Recruitment Status : Withdrawn (not enough patients meeting criteria)
First Posted : August 25, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Srijaya K. Reddy, MD, MBA, Children's Research Institute

Brief Summary:
Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children. However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in children undergoing posterior fossa surgery. In this prospective, randomized controlled trial, the investigators aim to determine whether the addition of IV acetaminophen for 24 hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical procedures of the posterior fossa compared with conventional therapy.

Condition or disease Intervention/treatment Phase
Arnold-Chiari Malformation Posterior Fossa Tumors Drug: IV acetaminophen Drug: normal saline Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery
Study Start Date : November 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV acetaminophen
IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
Drug: IV acetaminophen
IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
Other Names:
  • Tylenol
  • APAP

Placebo Comparator: normal saline
normal saline (placebo control) 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
Drug: normal saline
normal saline 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
Other Names:
  • saline placebo
  • NS 0.9%




Primary Outcome Measures :
  1. Daily opioid consumption (mg/kg/24 hours using morphine equivalent) [ Time Frame: 72 hours postoperatively ]
    Equianalgesic conversion of opioid consumption to morphine equivalent will be used


Secondary Outcome Measures :
  1. Average daily pain scores using Wong-Baker Faces or Numeric Pain Scale [ Time Frame: 72 hours postoperatively ]
    Scores range from 0 [no pain] to 10 [worst possible pain]

  2. Average daily sedation scores using University of Michigan Sedation Scale [ Time Frame: 72 hours postoperatively ]
    Score range from 0 [completely awake] to 4 [asleep but not responsive to any stimuli]

  3. Incidence of opioid-induced side effects [ Time Frame: 72 hours postoperatively ]
    1. Incidence of postoperative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics (i.e. ondansetron or promethazine given as needed)
    2. Incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic (i.e. diphenhydramine or hydroxyzine given as needed for pruritus)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any child undergoing posterior fossa surgery, including surgery for Chiari Malformation
  2. The subject's American Society of Anesthesiologists physical status is 1, 2 or 3
  3. Males and females 2 to 12 years old (minorities will be included) - recommended dosing of IV acetaminophen in children is approved for children 2 to 12 years of age
  4. Written informed consent from parent/guardian

Exclusion Criteria:

  1. Subjects with known or suspected hypersensitivity reaction to acetaminophen
  2. Presence or prior history of a known liver disease or coagulation disorder:
  3. History of abnormal liver function
  4. History of prior liver transplantation
  5. Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
  6. History of prior acetaminophen overdose
  7. Subjects with the need for mechanical ventilation prior to surgery or postoperatively - unable to assess accurate pain scores in this context
  8. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  9. The subject had a recent opioid exposure (within 1 month of surgery)
  10. The subject is obese (body mass index >30 kg/m2)
  11. The subject is an American Society of Anesthesiologist physical status classification of 4 or greater
  12. The subject is scheduled for a surgical sub-procedure
  13. Subjects who have been previously enrolled in this protocol may not be enrolled again

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): NCT02532322


Locations
Layout table for location information
United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Srijaya K. Reddy, MD, MBA
Investigators
Layout table for investigator information
Principal Investigator: Srijaya K Reddy, MD, MBA Children's National Health System

Publications:
Layout table for additonal information
Responsible Party: Srijaya K. Reddy, MD, MBA, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02532322     History of Changes
Other Study ID Numbers: PRO00006330
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Infratentorial Neoplasms
Arnold-Chiari Malformation
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics