Acetaminophen's Efficacy For Post-operative Pain

• ClinicalTrials.gov Identifier: NCT01721486
• Recruitment Status: Completed
• First Posted: November 4, 2012
• Results First Posted: June 8, 2017
• Last Update Posted: June 8, 2017
• Sponsor: Kaveh Aslani, MD
• Information provided by (Responsible Party): Kaveh Aslani, MD, William Beaumont Hospitals

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

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*

Contacts and Locations

Locations

United States, Michigan

Beaumont Health System

Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

Kaveh Aslani, MD

Investigators

• Principal Investigator: Kaveh Aslani, MD; William Beaumont Hospitals

More Information

• Responsible Party: Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT01721486
• Other Study ID Numbers: 2012-162
• First Posted: November 4, 2012
• 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:

tonsillitis; recurrent tonsillitis; obstructed air passages; swallowing difficulties

Additional relevant MeSH terms:

Tonsillitis; Deglutition Disorders; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Acetaminophen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics