Acetaminophen's Efficacy for Post-operative Pain Control
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tonsillitis Airway Obstruction Difficulty Swallowing |
Drug: IV acetaminophen Drug: PO acetaminophen |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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 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 prior to induction of anesthesia in the pre-operative area.
|
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 (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 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| Ages Eligible for Study: | 5 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Kaveh Aslani, MD, MD | 248-898-1907 | kaveh.aslani@beaumont.edu |
| Contact: Cynthia Turzewski, RN, BSN | 248-898-1907 | cynthia.turzewski@beaumont.edu |
| United States, Michigan | |
| Beaumont Health System | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Kaveh Aslani, MD 248-898-1907 Kaveh.aslani@beaumont.edu | |
| 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 |
More Information
No publications provided
| Responsible Party: | Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT01721486 History of Changes |
| Other Study ID Numbers: | 2012-162 |
| Study First Received: | September 27, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by William Beaumont Hospitals:
|
tonsillitis recurrent tonsillitis obstructed air passages swallowing difficulties |
Additional relevant MeSH terms:
|
Airway Obstruction Deglutition Disorders Tonsillitis Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Pharyngitis |
Stomatognathic Diseases Respiratory Tract Infections Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013