Phase 4
Completed N=74
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
tonsillectomy · Adenoidectomy
Source: ClinicalTrials.gov NCT02994940 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Total Dose of Opioid — 147.6; 125.4 mcg/kg — p=0.127
◆ Published Evidence
Established
▲ Trending
21citations · ~4 / year
Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial.
Summary
Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.
Linked Publications
-
Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dose of Opioid |
147.6; 125.4 | 0.127 |
| SECONDARY Proportion of Patients With Severe Pain Score of 7 or Higher |
15; 17 | 0.851 |
| SECONDARY Plasma Acetaminophen Level 1 - End of Surgery |
22; 20 | 0.109 |
| SECONDARY Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration |
18; 11 | 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).
Exclusion Criteria
- Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.
- Patients with a known allergy to acetaminophen
- Patients with known hepatic insufficiency or severe hepatic disease
- Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Patients who are malnourished (ie lower levels of glutathione)
- Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)
- Patients who are pregnant
Data sourced from ClinicalTrials.gov (NCT02994940) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.