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Onset of analgesia and analgesic efficacy of tramadol/acetaminophen and codeine/acetaminophen/ibuprofen in acute postoperative pain: A single-center, single-dose, randomized, active-controlled, parallel-group study in a dental surgery pain model

Authors
 Young-Soo Jung  ;  Dong Kee Kim  ;  Eui-Wung Lee  ;  In-Ho Cha  ;  Hyung-Jun Kim  ;  Moon-Key Kim 
Citation
 Clinical Therapeutics, Vol.26(7) : 1037-1045, 2004 
Journal Title
 Clinical Therapeutics 
ISSN
 0149-2918 
Issue Date
2004
MeSH
Acetaminophen/administration & dosage ; Acetaminophen/therapeutic use* ; Adolescent ; Adult ; Analgesia* ; Analgesics, Opioid/administration & dosage ; Analgesics, Opioid/therapeutic use* ; Codeine/administration & dosage ; Codeine/therapeutic use* ; Drug Combinations ; Female ; Humans ; Ibuprofen/administration & dosage ; Ibuprofen/therapeutic use* ; Male ; Pain, Postoperative/drug therapy* ; Pain, Postoperative/etiology ; Time Factors ; Tooth Extraction* ; Tramadol/administration & dosage ; Tramadol/therapeutic use*
Keywords
onset of analgesia ; analgesic combination ; analgesic efficacy ; tramadol/acetaminophen ; postoperative pain
Abstract
BACKGROUND: The combination of tramadol and acetaminophen has demonstrated good efficacy in various clinical pain models. However, there is a need for comparisons of the onset of analgesia and other measures of analgesic efficacy with this combination and other strong combination analgesics for the management of acute pain. OBJECTIVE: The goal of this study was to compare the time to onset of analgesia and other measures of analgesic efficacy with tramadol/acetaminophen 75/650 mg (Tr/Ac) and codeine/acetaminophen/ibuprofen 20/500/400 mg (Co/Ac/Ib) in the management of acute pain after oral surgery. METHODS: This was a single-center, single-dose, randomized, active-controlled, parallel-group study in healthy subjects who had undergone surgical extraction of > or =1 impacted third molar requiring bone removal. When patients reported at least moderate pain after dental surgery (score > or =5 on a 10-point scale), they were randomized to 1 of 2 treatment groups. The time to onset of analgesia was measured using a 2-stopwatch technique. The time to the onset of perceptible and meaningful pain relief, pain intensity, pain relief, patient's overall assessment, and adverse events were recorded for 6 hours after dosing. RESULTS: One hundred twenty-eight subjects participated in the study, 64 in each treatment group. The 2 groups were similar in terms of baseline pain severity and demographic characteristics (mean age, 23.7 and 23.4 years in the Tr/Ac and Co/Ac/Ib groups, respectively; mean body weight, 58.5 and 60.3 kg). The median times to the onset of perceptible pain relief were a respective 21.0 and 24.4 minutes, and the median times to the onset of meaningful pain relief were 56.4 and 57.3 minutes. Mean total pain relief and the sum of pain intensity difference were also similar in the early period after dosing (0-4 hours). However, between 4 and 6 hours, Co/Ac/Ib was associated with significant differences in both variables compared with Tr/Ac (P < 0.05). Although similar through the 4-hour assessment, mean pain intensity difference was significantly greater with Co/Ac/Ib at 5 to 6 hours. The proportion of patients assessing their assigned treatment as good or better was significantly greater with Co/Ac/Ib compared with Tr/Ac (P < 0.05). The safety profile of Tr/Ac was comparable to that of Co/Ac/Ib. CONCLUSIONS: In this small and selected group of subjects, the onset of analgesia and analgesic efficacy of Tr/Ac was comparable to that of Co/Ac/Ib. Tr/Ac provided rapid and effective analgesia for acute postoperative dental pain in this population.
Full Text
http://www.sciencedirect.com/science/article/pii/S0149291804901750
DOI
10.1016/S0149-2918(04)90175-0
Appears in Collections:
2. College of Dentistry (치과대학) > Dept. of Oral and Maxillofacial Surgery (구강악안면외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Dong Ki(김동기)
Kim, Hyung Jun(김형준) ORCID logo https://orcid.org/0000-0001-8247-4004
Jung, Young Soo(정영수) ORCID logo https://orcid.org/0000-0001-5831-6508
Cha, In Ho(차인호) ORCID logo https://orcid.org/0000-0001-8259-2190
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/111625
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