Acetaminophen's Efficacy For Post-operative Pain

NCT ID: NCT01721486

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Tonsillitis; Airway Obstruction; Difficulty Swallowing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Group

IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.

Group Type: EXPERIMENTAL

IV acetaminophen

Intervention Type: DRUG

IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .

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.

Group Type: ACTIVE_COMPARATOR

PO acetaminophen

Intervention Type: DRUG

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.

Interventions

IV acetaminophen

IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ofirmev; Acetaminophen Elixir

Eligibility 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*

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaveh Aslani, MD

OTHER

Sponsor Role: lead

Responsible Party

Kaveh Aslani, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kaveh Aslani, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Health System

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2012-162

Identifier Type: -

Identifier Source: org_study_id