Randomised controlled trial of tetanus treatment with antitetanus immunoglobulin by the intrathecal or intramuscular route.

OBJECTIVE To evaluate the effect of intrathecal therapy with human antitetanus immunoglobulin on clinical progression of and mortality from tetanus. DESIGN Randomised controlled trial. SETTING Intensive care unit of a university hospital, Pernambuco, Brazil. PARTICIPANTS 120 patients with tetanus allocated to antitetanus immunoglobulin by either the intrathecal and intramuscular route (n = 58) or the intramuscular route (n = 62; control group). MAIN OUTCOME MEASURES Clinical progression of disease, duration of hospital stay, duration of occurrence of spasms, complications, respiratory infection, respiratory failure or mechanical ventilation, duration of respiratory assistance, and mortality. RESULTS Patients in the treatment group showed a better clinical progression than those in the control group (chi2 for trend 7.752, P = 0.005; difference in proportion of patients with improvement 20%, 95% confidence interval 4% to 35%). The duration of occurrence of spasms, hospital stay, and respiratory assistance were all shorter in patients the treatment group: respectively, 14.96, 0.0001 (difference in proportion of patients with spasms lasting < or = 10 days 36%, 18% to 55%); 4.56, 0.03; and 6.56, 0.01 (proportion of patients who needed assistance for < or = 10 days 69.2% in the treatment group and 30.8% in the control group (difference 38%, 12% to 65%)). CONCLUSION Patients treated with antitetanus immunoglobulin by the intrathecal route show better clinical progression than those treated by the intramuscular route.