Abstract
The influence of caffeine (Caf.) on the analgesic effect of acetoaminophen (APAP.) for relief of post exodontic pain was studied in a double blind comparative study.
The medicine used for this study was divided into the following four groups : Group A APAP. 400 mg; Group B, APAP. 400 mg plus Cal. 60 mg; Group C, APAP. 600 mg plus Cal. 90 mg; and Group D, APAP. 600 mg plus Cal. 120 mg.
It was confirmed by an independent controller that the capsules containing medicine could not be distinguished from each other by outlook.
The population that participated in the study consisted of patients who were expected to have pain after tooth extractions.The following persons were excluded from the study : those whose age was under 14 years old or over 75 years old ; those who were pregnant as well as those assumed to be pregnant ; those who had an ulcerative gastro-intestinal disease as well as those who had had one in the past; those who had medicament allergy ; and those whom the attending doctor considered inappropriate for the study for other reasons.
The medicine was administered to 593 persons, out of whom 112 were excluded from the study since they had not taken the medicine. Fifty more persons were dropped out because they had not followed the instructions given as how to take the medicine. Thus, the number of cases used for the statistical analysis totaled 431, out of which 104 constituted Group A ; 119 Group B ; 106 Group C and 102 Group D.
As for the background of these cases prior to the study, there was no statistical deviation among Groups A, B and C, but a slight deviation was observed between Group D and the other groups in items of such things as the time required for tooth extraction. However, no deviation was observed in other major items. Therefore, it was decided that the differences among the groups do not interfere with the validity of a double blind comparative study.
The following results were obtained from the study.
1) According to a subjective assessment of the patients, no significant differences were recognized among Groups A, B and C, while it was recognized that Group D tended to have less effect than the others.
2) According to a comprehensive assessment done by the attending doctors, no significant statistical differences were recognized among Groups A, B and C, while Group D had less effect than the others (p<0.05) .
3) In items of the time lag from the beginning of medication to analgesic effect, no significant statistical differences were recognized among Groups A, B and C, while Group D was recognized as being slower than the others (p<0.05) .
4) No noteworthy side effects were recognized in any patient in this study.
With the above-mentioned results, it was concluded that Caf. did not increase the analgesic effect of APAP. on the relief of post exodontic pain.
