Acetaminophen's Efficacy for Post-operative Pain Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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 26, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Tonsillitis
Airway Obstruction
Difficulty Swallowing
Drug: IV acetaminophen
Drug: PO acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: EFFICACY OF IV VS ORAL ADMINISTRATION OF ACETAMINOPHEN FOR PAIN CONTROL FOLLOWING TONSILLECTOMY WITH OR WITHOUT ADENOIDECTOMY

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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*
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721486

Contacts
Contact: Kaveh Aslani,, MD 248-898-1907 kaveh.aslani@beaumont.edu
Contact: Cynthia Turzewski, RN, BSN 248-898-1907 cynthia.turzewski@beaumont.edu

Locations
United States, Michigan
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kaveh Aslani, MD    248-898-1907    Kaveh.aslani@beaumont.edu   
Contact: Cynthia Turzewski,RN, BSN    248-898-1907    Cynthia.Turzewksi@beaumont.edu   
Principal Investigator: Kaveh Aslani, MD         
Sponsors and Collaborators
Kaveh Aslani, MD
Investigators
Principal Investigator: Kaveh Aslani, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01721486     History of Changes
Other Study ID Numbers: 2012-162
Study First Received: September 27, 2012
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
tonsillitis
recurrent tonsillitis
obstructed air passages
swallowing difficulties

Additional relevant MeSH terms:
Tonsillitis
Airway Obstruction
Deglutition Disorders
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 29, 2014