Phase 4 Completed N=41 Randomized Double-blind Treatment

Acetaminophen's Efficacy For Post-operative Pain

tonsillitis · Airway Obstruction · Difficulty Swallowing

Source: ClinicalTrials.gov NCT01721486 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Jun 2017

Primary outcomePrimary: Total Pain Medication — 1.7; 2.2 mg

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Pain Medication	1.7; 2.2	—
SECONDARY FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores	0; 0	—
SECONDARY Incidence of Post-operative Vomiting	1; 3	—
SECONDARY Parental Satisfaction With Pain Control.	9; 8	—

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*

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01721486). 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.