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Intramuscular haloperidol plus promethazine is more effective and safer than haloperidol alone for rapid tranquillisation of agitated mentally ill patients

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G Huf

Correspondence to: G Huf, National Institute of Quality Control in Health, Oswaldo Cruz Foundation, Av Brasil 4365, Manguinhos, 21040-900, Rio de Janeiro, Brazil; gisele@ensp.fiocruz.br

QUESTION

Question:

Is haloperidol alone more effective than haloperidol plus promethazine for rapid tranquillisation of mentally ill patients?

Patients:

316 adults presenting to the psychiatric emergency room with agitation or dangerous behaviour requiring intramuscular sedation, for whom an attending doctor was available to record the diagnosis and severity of the episode.

Setting:

One psychiatric emergency room, Rio de Janeiro, Brazil; January 2004 to July 2004.

Intervention:

Single intramuscular injection of haloperidol (5 or 10 mg) or haloperidol (5 or 10 mg) plus promethazine (up to 50 mg). In the haloperidol alone group, 29% received 5 mg and 71% received 10 mg. In the haloperidol plus promethazine group 50% received 5 mg haloperidol and 50% received 10 mg.

Outcomes:

Primary outcome: proportion of patients tranquil (calm and non-agitated with no threatening behaviour) or asleep at 20 min. Secondary outcomes included: tranquil or asleep at 40, 60 and 120 min; need for further medical attention within 24 h; adverse events.

Patient follow-up:

Data available for 98.4% for the primary outcome; 100% analysed in conservative intention to treat analysis.

METHODS

Design:

Pragmatic randomised controlled trial.

Allocation:

Concealed.

Blinding:

Unblinded.

Follow-up period:

20 min following antipsychotic injection (primary outcome); 40, 60, and 120 min, 24 h and 2 weeks following (secondary outcomes). …

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