Hydrocodone/acetaminophen and tramadol chlorhydrate combination tablets for the management of chronic cancer pain: a double-blind comparative trial.
OBJECTIVE
The purpose of this study was to compare the analgesic efficacy and tolerability of opioids hydrocodone and tramadol in the relief of cancer pain.


METHODS
One hundred and eighteen patients with chronic cancer pain participated in a double-blind, randomized controlled trial. Sixty-two patients received hydrocodone and 56 patients received tramadol.


RESULTS
Hydrocodone/acetaminophen was effective in relieving pain in 56.5% of the patients at the starting dose of 25 mg/2500 mg/d. An additional 14.5% of the patients responded to a double dose, and the remaining 29% of patients did not experience any pain relief from hydrocodone administration. One dose of tramadol at 200 mg/d produced pain relief in 62% of the patients and alleviated pain in another 11% of patients at a dose of 400 mg/d, and remaining 27% of patients did not experience pain relief from tramadol. No significant statistical difference in the analgesic efficacy of tramadol clorhydrate and hydrocodone/acetaminophen was found. The groups differed significantly in the incidence of side effects like nausea (P=0.03; relative risk (RR), 1.69; confidence interval (IC) 95%, 1.03-2.77), vomiting (P=0.02; RR, 2.21; IC 95%, 1.14-4.32), dizziness (P=0.03; RR, 2.12; IC 95%, 1.17-3.86), loss of appetite (P=0.02; RR, 3.27; IC 95%, 1.12-9.55) and weakness (P=0.019; RR, 7.75; IC 95%, 0.98-61.05).


CONCLUSIONS
There was no superior analgesic efficacy with the administration of hydrocodone/acetaminophen when compared to patients receiving tramadol in the relief of cancer pain. Tramadol produced more mild side effects than hydrocodone.
Rodriguez
Rene Fernando
RF
Universidad Libre de Cali, Cali, Valle, Colombia. renerodriguez@hotmail.com
Castillo
Javier M
JM
Castillo
María P
MP
Montoya
Olga
O
Daza
Paola
P
Rodríguez
Mario F
MF
Restrepo
José M
JM
León
Miguel E
ME
Angel
Ana M
AM
D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D013607:Tablets; D014147:Tramadol / Q000627:therapeutic use*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D013607:Tablets; D000082:Acetaminophen; D014147:Tramadol; D006853:Hydrocodone