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Trial record 70 of 1877 for:    Acetaminophen

Acetaminophen's Efficacy For Post-operative Pain

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. Identifier: NCT01721486
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals

Brief Summary:
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 or disease Intervention/treatment Phase
Tonsillitis Airway Obstruction Difficulty Swallowing Drug: IV acetaminophen Drug: PO acetaminophen Phase 4

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 (NSAIDs), such as ibuprofen by mouth (PO) or ketorolac intravenous (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arm Intervention/treatment
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 .
Other Name: Ofirmev

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.
Other Name: Acetaminophen Elixir

Primary Outcome Measures :
  1. Total Pain Medication [ Time Frame: From time of PACU admission until 24 hours post-operatively. ]
    All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.

Secondary Outcome Measures :
  1. FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores [ Time Frame: At time of admission into PACU. ]
    FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.

  2. 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. ]
    Percentage of subjects with at least one episode of post-operative vomiting

  3. Parental Satisfaction With Pain Control. [ Time Frame: 24 hours post hospital discharge. ]
    Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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*

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 identifier (NCT number): NCT01721486

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United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kaveh Aslani, MD
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Principal Investigator: Kaveh Aslani, MD William Beaumont Hospitals

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Responsible Party: Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01721486     History of Changes
Other Study ID Numbers: 2012-162
First Posted: November 5, 2012    Key Record Dates
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kaveh Aslani, MD, William Beaumont Hospitals:
recurrent tonsillitis
obstructed air passages
swallowing difficulties
Additional relevant MeSH terms:
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Deglutition Disorders
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs