Clinical trial NCT01721486: Acetaminophen's Efficacy For Post-operative Pain
Official title: Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillitis
Airway Obstruction
Difficulty Swallowing
Keywords: tonsillitis
recurrent tonsillitis
obstructed air passages
swallowing difficulties
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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\*

Primary outcomes:
measure: Total Pain Medication
timeFrame: From time of PACU admission until 24 hours post-operatively.
Secondary outcomes:
measure: FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
timeFrame: At time of admission into PACU.
measure: Incidence of Post-operative Vomiting
timeFrame: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.
measure: Parental Satisfaction With Pain Control.
timeFrame: 24 hours post hospital discharge.
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kaveh Aslani, MD
role: PRINCIPAL_INVESTIGATOR
References: