[A randomized, double blind, and controlled clinical trial of the non-addictive propacetamol in postoperative analgesia].
OBJECTIVE
To compare the postoperative analgesic efficacy and safety of the non-addictive propacetamol hydrochloride (Pro-Bufferin) injection and dolantin in a prospective, randomized, double blind and controlled clinical trial.


METHODS
After the pain intensity was assessed when the patients were undergone thoracic and abdominal selective surgery became fully conscious, 40 consecutive patients with moderate to severe postoperative pain (equivalent to Pain Grade I and II of American Anesthesia Association classification) were randomized into the study against the control groups. The two groups were similar for age, sex, height/weight, disease categories, operation categories, anesthesia methods and duration, vital signs, hepatorenal function, and blood cell count (P = 0.06-0.93). In the study group, 2 g propacetamol in 100 ml normal saline (NS) intravenously with 1.0 ml NS intramuscularly as the placebo control to dolantin were administered. In the control group, 1.6 g mannitose in 100 ml NS intravenously as the placebo control to propacetamol with 50 mg dolantin (1.0 ml) intramuscularly as the positive control to propacetamol were administered. The intensity change of postoperative pain was then evaluated 10 times with visual analog scale and verbal describing scale during 6 h from the beginning of propacetamol infusion. Vital signs and adverse reactions were also documented. After all data were put into the computer, the blinding codes were decoded and the statistic analysis was then made.


RESULTS
There was no significant difference (P = 0.93) about the area under the curve of "Pain Relieve Score vs. Time". The "starting to effect" time (15-30 min), analgesic duration (6 h) and the percentage of excellent or good analgesic effect (90%) in the two groups were the same. Adverse reactions didn't reached the statistic different level (P = 0.35).


CONCLUSIONS
Propacetamol HCL injection 2 g intravenously could be an alternative to dolantin 50 mg intramuscularly for moderate to severe postoperative pain with its advantage of being non-addictive.
Ma
En-ling
EL
Department of Surgery, PUMC Hospital, CAMS, PUMC, Beijing 100730, China. enlingma@sohu.com
Wang
Xiu-rong
XR
Jiang
Zhu-ming
ZM
Cui
Yu
Y
Wang
Rong
R
Liu
Jia
J
D000082:Acetaminophen / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008614:Meperidine / Q000627:therapeutic use; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*
D000700:Analgesics; D000082:Acetaminophen; C063776:propacetamol; D008614:Meperidine