Acetaminophen's Efficacy For Post-operative Pain
Primary Purpose
Tonsillitis, Airway Obstruction, Difficulty Swallowing
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV acetaminophen
PO acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillitis focused on measuring tonsillitis, recurrent tonsillitis, obstructed air passages, swallowing difficulties
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*
Sites / Locations
- Beaumont Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Group
Control Group
Arm Description
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
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.
Outcomes
Primary Outcome Measures
Total Pain Medication
All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Secondary Outcome Measures
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.
Incidence of Post-operative Vomiting
Percentage of subjects with at least one episode of post-operative vomiting
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01721486
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kaveh Aslani, MD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Airway Obstruction, Difficulty Swallowing
Keywords
tonsillitis, recurrent tonsillitis, obstructed air passages, swallowing difficulties
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .
Intervention Type
Drug
Intervention Name(s)
PO acetaminophen
Other Intervention Name(s)
Acetaminophen Elixir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Pain Medication
Description
All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Time Frame
From time of PACU admission until 24 hours post-operatively.
Secondary Outcome Measure Information:
Title
FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
Description
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.
Time Frame
At time of admission into PACU.
Title
Incidence of Post-operative Vomiting
Description
Percentage of subjects with at least one episode 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.
Title
Parental Satisfaction With Pain Control.
Description
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.
Time Frame
24 hours post hospital discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaveh Aslani, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Acetaminophen's Efficacy For Post-operative Pain
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