Phase 4
N=73
Pre-emptive Analgesics in Orthodontic Treatment
NSAID · Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT03523988 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment — 0.6; 2.6; 1.0; 2.0 scores on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Ibuprofen (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment |
0.6; 2.6; 1.0; 2.0; 2.9; 2.0 | 0.04 sig |
| PRIMARY Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment |
1.9; 2.0; 1.1; 2.9; 2.5; 2.1 | 0.65 |
| PRIMARY Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment |
1.3; 1.4; 0.4; 2.3; 2.3; 0.9 | 0.53 |
Summary
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.
Eligibility Criteria
Inclusion Criteria
-Orthodontic patient presenting for orthodontic treatment
Exclusion Criteria
- History of taking an analgesic in the past six hours
- Hypersensitivity to ibuprofen or acetaminophen
- Aspirin-sensitive asthma
- Renal or liver impairment
- History of GI bleeding or ulcers
- Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
- Currently taking antibiotics or other medications for a chronic systemic disease
- Bleeding disorder
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03523988). 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.