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Trial record 2 of 8 for:    dashti

Analgesic Effect of IV Acetaminophen in Tonsillectomies

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: NCT01691690
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE September 25, 2012
Results First Submitted Date  ICMJE September 7, 2016
Results First Posted Date  ICMJE April 6, 2017
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
FLACC Pain Score Greater Than or Equal to 4 [ Time Frame: 0-60 mins post-operatively ]
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
Analgesic efficacy of single dose intravenous acetaminophen in pediatric patients undergoing tonsillectomy by means of opioid consumption and pain scores in the first 8-12 postoperative hours. [ Time Frame: 8-12 hours post-operatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each [ Time Frame: 8-12 hours post-operatively ]
    Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
  • Time of First Opioid Analgesia in PACU [ Time Frame: 0-90 minutes post-operatively ]
    Mean time to first drug administration among patients requiring opioid analgesia in the PACU.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
Recovery characteristics in the PACU and floor in patients following tonsillectomy. [ Time Frame: 8-12 hours post-operatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effect of IV Acetaminophen in Tonsillectomies
Official Title  ICMJE Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy
Brief Summary

Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.

Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).

To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

Detailed Description

Once enrolled, subjects will have a standardized anesthetic on the day of surgery:

  1. Pre-medication with oral midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction
  2. Inhalation induction with sevoflurane and a mixture of N20/02
  3. Propofol 1-1.5 mg/kg to facilitate endotracheal intubation
  4. Morphine 0.1 mg/kg given prior to intubation
  5. Maintenance anesthesia with isoflurane, titrated to 0.8-1 Minimal Anesthetic Concentration (MAC) with a mixture of Air/02
  6. Acetaminophen IV (15 mg/kg) vs. saline placebo infused intraoperatively (randomized by pharmacy)
  7. Ondansetron (0.15 mg/kg, maximum dose of 4 mg) and dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.

Following surgery and extubation, baseline vitals will be obtained and pain scores will be assessed in the post anesthesia care unit (PACU) via Faces, Legs, Activity, Cry, Consolability Scale (FLACC).The presence of emergence delirium will be assessed via Pediatric Agitation and Emergence Delirium scale (PAED). Those subjects whose pain score is assessed at < 4 will receive standard postoperative care and no analgesics. Assessed pain scores > 4 will receive 0.5mcg/kg fentanyl q10 minutes as needed. Variables such as time to extubation in the PACU, time to first analgesic delivery, pain scores, # times/total dose of opioids given, presence of sedation, nausea/vomiting, duration of oxygen requirement in PACU, whether or not patient was discharged to floor on oxygen and total PACU time will be recorded during the duration of the patient's PACU stay. Subjects will be discharged to the inpatient floor from the PACU once standard discharge criteria have been met.

Following discharge from the PACU, standardized analgesics will be given for breakthrough pain (oral oxycodone 0.1mg/kg q4hrs pro re nata (PRN) pain). Enrolled patients will be followed during the duration of their inpatient stay. Duration of oxygen requirement on the floor, pain scores and number of administered oxycodone doses on the floor will be monitored and recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenotonsillitis
  • Tonsillitis
Intervention  ICMJE
  • Drug: Acetaminophen (paracetamol)
    Acetaminophen IV (15 mg/kg).
  • Drug: Normal Saline Flush
    Saline placebo will be infused intraoperatively.
  • Drug: Midazolam
    Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
    Other Name: Versed
  • Drug: Sevoflurane
    Sevoflurane for anesthesia induction.
  • Drug: Nitrous Oxide/Oxygen
    Combination of NO2 & O2 for anesthesia induction.
  • Drug: Propofol
    Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
  • Drug: Morphine
    Morphine 0.1 mg/kg given prior to intubation.
  • Drug: Ondansetron
    Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
    Other Name: Zofran
  • Drug: Dexamethasone
    Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.
Study Arms  ICMJE
  • Experimental: IV Acetaminophen
    Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..
    Interventions:
    • Drug: Acetaminophen (paracetamol)
    • Drug: Midazolam
    • Drug: Sevoflurane
    • Drug: Nitrous Oxide/Oxygen
    • Drug: Propofol
    • Drug: Morphine
    • Drug: Ondansetron
    • Drug: Dexamethasone
  • Placebo Comparator: Saline placebo infused intraoperatively
    For this arm Morphine will be administered to manage pain.
    Interventions:
    • Drug: Normal Saline Flush
    • Drug: Midazolam
    • Drug: Sevoflurane
    • Drug: Nitrous Oxide/Oxygen
    • Drug: Propofol
    • Drug: Morphine
    • Drug: Ondansetron
    • Drug: Dexamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2017)
250
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
240
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients aged 2 years and younger than 9 years old requiring postoperative admission for tonsillectomy or adenotonsillectomy.
  2. Functional status as assigned by the American Society of Anesthesiology (ASA) classification of I (1), II (2) or III (3).
  3. Have a parent/guardian who are able to provide written informed consent in accordance with Human Investigations Committee/Institutional Review Board (HIC/IRB) regulations.
  4. Have parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent.

Exclusion Criteria:

  1. Male or female patients age greater than 9 years.
  2. Have an American Society of Anesthesiologists Physical Status > IV (4)(severe disease that is life threatening).
  3. Have a known hypersensitivity or allergy to acetaminophen.
  4. Have a known allergy or intolerance to morphine or fentanyl.
  5. Have received chronic opioid analgesic therapy prior to surgery.
  6. Have renal disease.
  7. Have hepatic disease.
  8. Are morbidly obese (% BMI > 95).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01691690
Other Study ID Numbers  ICMJE IRB12-00097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arlyne Thung, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arlyne Thung, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP