Acetaminophen's Efficacy For Post-operative Pain

Airway Obstruction Clinical Trial

Official title:

Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721486
• Other study ID #: 2012-162
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2012
• Last updated: June 6, 2017
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2017
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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*

Related Conditions & MeSH terms

• Airway Obstruction
• Deglutition Disorders
• Difficulty Swallowing
• Tonsillitis

Intervention

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

Locations

Country	Name	City	State
United States	Beaumont Health System	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Kaveh Aslani, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Pain Medication	All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.	From time of PACU admission until 24 hours post-operatively.
Secondary	FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores	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.	At time of admission into PACU.
Secondary	Incidence of Post-operative Vomiting	Percentage of subjects with at least one episode of post-operative vomiting	From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.
Secondary	Parental Satisfaction With Pain Control.	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.	24 hours post hospital discharge.