Acetaminophen's Efficacy for Post-operative Pain Control

This study is currently recruiting participants.
Verified June 2013 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01721486
First received: September 27, 2012
Last updated: June 25, 2013
Last verified: June 2013

September 27, 2012
June 25, 2013
September 2012
September 2013   (final data collection date for primary outcome measure)
Total pain medication from time of PACU admission until 24 hours post-operatively as documented by all pain given. [ Time Frame: The timeframe is 24 hours. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01721486 on ClinicalTrials.gov Archive Site
  • Post-operative FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) pain assessment scores. [ Time Frame: Admission into PACU and every 10 minutes until hospital discharge, between 1 - 2 hours. At the conclusion of enrollment, this measure will be assessed for all participants. ] [ Designated as safety issue: No ]
  • Incidence of post-operative vomiting [ Time Frame: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants. ] [ Designated as safety issue: No ]
  • Parental satisfaction with pain control, as measured by a 10 point Likert scale. [ Time Frame: Telephone call to parents at 24 hours post hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acetaminophen's Efficacy for Post-operative Pain Control
EFFICACY OF IV VS ORAL ADMINISTRATION OF ACETAMINOPHEN FOR PAIN CONTROL FOLLOWING TONSILLECTOMY WITH OR WITHOUT ADENOIDECTOMY

The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction, the procedure can result in significant post-operative pain. Common analgesic techniques include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAID, such as ibuprofen PO or ketorolac IV), and narcotics. Acetaminophen has been shown to be effective in reducing pain and post-operative opioid requirements. Its administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are effective for pain control but increase the risk of nausea and vomiting. They also have the potential to cause respiratory depression.

IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an adjunct to opioids for severe pain. Several studies have examined the efficacy of IV acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR), tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the efficacy of oral vs IV administration for pain control post-tonsillectomy in children.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Tonsillitis
  • Airway Obstruction
  • Difficulty Swallowing
  • Drug: IV acetaminophen
    IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
  • Drug: PO acetaminophen
    PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
  • Experimental: Study Group
    IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
    Intervention: Drug: IV acetaminophen
  • Active Comparator: Control Group
    PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
    Intervention: Drug: PO acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 5-13 years of age
  • Surgical procedure: tonsillectomy with or without adenoidectomy
  • American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

Exclusion Criteria:

  • Known allergy to study medication(s)
  • Known genetic abnormality
  • Known hepatitis
  • Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
  • Children who have taken any analgesic within 24 hours prior to surgery
  • Enrollment in concurrent research study
  • Pregnant patients*
  • Students/trainees/staff*
  • Mentally disabled/cognitively impaired*
Both
5 Years to 13 Years
No
Contact: Kaveh Aslani,, MD 248-898-1907 kaveh.aslani@beaumont.edu
Contact: Cynthia Turzewski, RN, BSN 248-898-1907 cynthia.turzewski@beaumont.edu
United States
 
NCT01721486
2012-162
Yes
Kaveh Aslani, MD, William Beaumont Hospitals
Kaveh Aslani, MD
Not Provided
Principal Investigator: Kaveh Aslani, MD William Beaumont Hospitals
William Beaumont Hospitals
June 2013

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