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Analgesic Effect of IV Acetaminophen in Tonsillectomies

Primary Purpose

Adenotonsillitis, Tonsillitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen (paracetamol)
Normal Saline Flush
Midazolam
Sevoflurane
Nitrous Oxide/Oxygen
Propofol
Morphine
Ondansetron
Dexamethasone
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenotonsillitis

Eligibility Criteria

2 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Acetaminophen

Saline placebo infused intraoperatively

Arm Description

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..

For this arm Morphine will be administered to manage pain.

Outcomes

Primary Outcome Measures

FLACC Pain Score Greater Than or Equal to 4
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.

Secondary Outcome Measures

Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
Time of First Opioid Analgesia in PACU
Mean time to first drug administration among patients requiring opioid analgesia in the PACU.

Full Information

First Posted
May 30, 2012
Last Updated
February 21, 2017
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01691690
Brief Title
Analgesic Effect of IV Acetaminophen in Tonsillectomies
Official Title
Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenotonsillitis, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm Description
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..
Arm Title
Saline placebo infused intraoperatively
Arm Type
Placebo Comparator
Arm Description
For this arm Morphine will be administered to manage pain.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen (paracetamol)
Intervention Description
Acetaminophen IV (15 mg/kg).
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush
Intervention Description
Saline placebo will be infused intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane for anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide/Oxygen
Intervention Description
Combination of NO2 & O2 for anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine 0.1 mg/kg given prior to intubation.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.
Primary Outcome Measure Information:
Title
FLACC Pain Score Greater Than or Equal to 4
Description
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.
Time Frame
0-60 mins post-operatively
Secondary Outcome Measure Information:
Title
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
Description
Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
Time Frame
8-12 hours post-operatively
Title
Time of First Opioid Analgesia in PACU
Description
Mean time to first drug administration among patients requiring opioid analgesia in the PACU.
Time Frame
0-90 minutes post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged 2 years and younger than 9 years old requiring postoperative admission for tonsillectomy or adenotonsillectomy. Functional status as assigned by the American Society of Anesthesiology (ASA) classification of I (1), II (2) or III (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. 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: Male or female patients age greater than 9 years. Have an American Society of Anesthesiologists Physical Status > IV (4)(severe disease that is life threatening). Have a known hypersensitivity or allergy to acetaminophen. Have a known allergy or intolerance to morphine or fentanyl. Have received chronic opioid analgesic therapy prior to surgery. Have renal disease. Have hepatic disease. Are morbidly obese (% BMI > 95).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlyne Thung, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18811827
Citation
Anderson BJ. Paracetamol (Acetaminophen): mechanisms of action. Paediatr Anaesth. 2008 Oct;18(10):915-21. doi: 10.1111/j.1460-9592.2008.02764.x.
Results Reference
background
PubMed Identifier
21627768
Citation
Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31.
Results Reference
background
PubMed Identifier
10443608
Citation
Korpela R, Korvenoja P, Meretoja OA. Morphine-sparing effect of acetaminophen in pediatric day-case surgery. Anesthesiology. 1999 Aug;91(2):442-7. doi: 10.1097/00000542-199908000-00019.
Results Reference
background
PubMed Identifier
19583073
Citation
Dashti GA, Amini S, Zanguee E. The prophylactic effect of rectal acetaminophen on postoperative pain and opioid requirements after adenotonsillectomy in children. Middle East J Anaesthesiol. 2009 Jun;20(2):245-9.
Results Reference
background
PubMed Identifier
20693884
Citation
Hong JY, Kim WO, Koo BN, Cho JS, Suk EH, Kil HK. Fentanyl-sparing effect of acetaminophen as a mixture of fentanyl in intravenous parent-/nurse-controlled analgesia after pediatric ureteroneocystostomy. Anesthesiology. 2010 Sep;113(3):672-7. doi: 10.1097/ALN.0b013e3181e2c34b.
Results Reference
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Analgesic Effect of IV Acetaminophen in Tonsillectomies

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