Acetaminophen's Efficacy for Post-operative Pain Control
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.
Drug: IV acetaminophen
Drug: PO acetaminophen
|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|
- 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 ]
- 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 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
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.
|Contact: Kaveh Aslani,, MDfirstname.lastname@example.org|
|Contact: Cynthia Turzewski, RN, BSNemail@example.com|
|United States, Michigan|
|Beaumont Health System||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Kaveh Aslani, MD 248-898-1907 Kaveh.firstname.lastname@example.org|
|Contact: Cynthia Turzewski,RN, BSN 248-898-1907 Cynthia.Turzewksi@beaumont.edu|
|Principal Investigator: Kaveh Aslani, MD|
|Principal Investigator:||Kaveh Aslani, MD||William Beaumont Hospitals|