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Completed

NCT Number: NCT01721486

Acetaminophen's Efficacy For Post-operative Pain

The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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*

Treatment and study plan

IV acetaminophen

Drug

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

Other names: Ofirmev

PO Acetaminophen

Drug

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 names: Acetaminophen Elixir

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaveh Aslani, MD

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 5, 2012
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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