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Acute painful sickle cell crises in children a double blind placebo controlled evaluation of efficacy and safety of cetiedil

Acute painful sickle cell crises in children a double blind placebo controlled evaluation of efficacy and safety of cetiedil

Clinical Trials Journal 20(4): 207-218

In the 1st part of the study, 18 pediatric patients (aged 4-19 yr) with confirmed sickle-cell disease, were given a single dose of cetiedil (average 0.37 mg/kg) or its matching placebo solution by i.v. infusion over 30-45 min and the severity of pain was evaluated after 0, 1, 2, 4 and 6 h. After 6 h, either cetiedil or matching placebo was crossed over in a randomized code and sequence. After 12 h, each patient received an infusion of cetiedil (average 0.37 mg/kg) at 6 h, intervals until the end of the acute painful crisis. Thirty children, also in acute sickle cell crisis, were divided into 2 groups of 15 in the 2nd part of the study, according to a randomized, double-blind code. One group received cetiedil (0.37 mg/kg) by i.v. infusion every 6 h for 4 consecutive days, the other received a matching placebo infusion. Pain was evaluated at 0, 1, 2, 4 and 6 h from the start of the infusions. Each patient was observed for a further 3 days and the time the crisis ended was recorded. Details of all patients, pain ratings of the various tests, examinations made and definition of sickle-cell crises and their termination are given. Cetiedil gave measurable pain relief whether it was given initially or after cross-over from placebo. The pain relief lasted for 6-7 h after the cetiedil infusion. All patients showed a definite reduction in the number of sickled cells in the blood. A single injection of 0.37 .+-. 0.04 mg/kg of cetiedil gave a significant reduction in pain intensity. In 9 cetiedil-treated homozygotes, the pain reduction from grade 2.3 to less than 1.0 lasted for 24 h. Four patients complained of vertigo in the 2nd part of the study, 3 in the cetiedil group and 1 in the placebo group. Cardiac rate, blood pressure and respiratory rate were essentially unchanged in the 2 groups.

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Accession: 004671573

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