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

Abstract

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.