Phase 4
N=41
Acetaminophen's Efficacy For Post-operative Pain
Tonsillitis · Airway Obstruction · Difficulty Swallowing
Bottom Line
View on ClinicalTrials.gov: NCT01721486 ↗Enrolled (actual)
41
Serious AEs
2.6%
Results posted
Jun 2017
Primary outcome: Primary: Total Pain Medication — 1.7; 2.2 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IV acetaminophen (Drug); PO acetaminophen (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Kaveh Aslani, MD
- Primary completion
- Sep 2014
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 | — |
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.
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*
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.