Jordan DM, Fricke JR, Jordan DM, Hewitt DJ, Rosenthal N, Karim MR; AcademyHealth. Meeting (2005 : Boston, Mass.).
Abstr AcademyHealth Meet. 2005; 22: abstract no. 4119.
CNS Projects, Ortho-McNeil Pharmaceutical, 1000 Route 202, Raritan, NJ 08869-0602 Tel. (908) 704-5833 Fax (908) 218-7051
RESEARCH OBJECTIVE: To compare the efficacy and safety of tramadol 37.5 mg/acetaminophen (APAP) 325 mg tablets and hydrocodone bitartrate10 mg/APAP 650 mg tablets for dental pain. STUDY DESIGN: Randomized, doubled-blind, placebo- and active-controlled, single-dose, parallel study. Subjects received 1 or 2 tramadol/APAP tablets, 1 hydrocodone/APAP tablet, or placebo. Pain intensity and relief were reported 30 minutes and then hourly for 8 hours, and time to onset of perceptible pain relief was recorded. Summary scores of pain relief and intensity over 4 hours and 8 hours were primary outcomes. POPULATION STUDIED: Two hundred adults experiencing at least moderate pain (Pain Visual Analog Score >=50/100 mm) following extraction of >=2 impacted third molars. PRINCIPAL FINDINGS: Baseline characteristics were similar among groups. One tramadol/APAP tablet was more effective than placebo for select outcomes over 4 hours; two tramadol/APAP tablets and one hydrocodone/APAP tablet were more effective than placebo for up to 8 hours. Among treatment groups, two tramadol/APAP tablets were more effective than one tramadol/APAP tablet over 4 hours: total pain relief (TOTPAR, P = .031), sum of pain intensity differences (SPID, P = .017), and sum of pain relief and intensity differences (SPRID, P = .023). Two tramadol/APAP tablets were comparable to hydrocodone/APAP throughout: TOTPAR (P >= .082), SPID (P >=.144), and SPRID (P >= .095). All treatments had faster onset than placebo; median onset of perceptible pain relief for two tramadol/APAP tablets was 33.3 minutes. The overall incidence of adverse events was lower for tramadol/APAP tablets than for hydrocodone/APAP or placebo, and the incidence of nausea and vomiting with two tramadol/APAP tablets was approximately 50% less than in the hydrocodone/APAP group. CONCLUSIONS: Tramadol/APAP tablets provide rapid, dose-dependent pain relief. The use of two tramadol/APAP tablets is an effective and safe alternative to hydrocodone/APAP for dental pain. IMPLICATIONS FOR POLICY, DELIVERY OR PRACTICE: Tramadol/APAP should be considered as an alternative to high-dose hydrocodone/APAP in the treatment of acute pain on account of its efficacy and favorable tolerability profile.
Publication Types:
Keywords:
- Acetaminophen
- Adult
- Analgesia
- Double-Blind Method
- Drug Combinations
- Humans
- Hydrocodone
- Molar, Third
- Nausea
- Pain
- Pain Measurement
- Placebos
- Toothache
- Tramadol
- Ultracet
- hsrmtgs
UI: 103623582
From Meeting Abstracts