+ Site Statistics
References:
54,258,434
Abstracts:
29,560,870
PMIDs:
28,072,757
+ Search Articles
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ PDF Full Text
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Translate
+ Recently Requested

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.

(PDF emailed within 1 workday: $29.90)

Accession: 004671573

Download citation: RISBibTeXText


Related references

Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 388(10052): 1408-1416, 2016

Evaluation of the efficacy and safety of dienogest in the treatment of painful symptoms in patients with adenomyosis: a randomized, double-blind, multicenter, placebo-controlled study. Fertility and Sterility 108(4): 673-678, 2017

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study. International Journal of Pediatrics 2015: 141767, 2015

Dexamethasone shortens the duration of painful events requiring hospitalization in children with sickle cell disease Results of a randomized, double-blind, placebo-controlled trial. Blood 86(10 SUPPL 1): 250A, 1995

A double-blind, placebo-controlled phase II study of the efficacy and safety of 2,2-dimethylbutyrate (HQK-1001), an oral fetal globin inducer, in sickle cell disease. American Journal of Hematology 89(7): 709-713, 2014

Efficacy and safety of topiramate in the treatment of painful diabetic neuropathy A double-blind, placebo-controlled study. Neurology 54(7 Supp 3): A81, April 11, 2000

Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. Bmc Neurology 8: 33, 2008

Improvements in haemolysis and indicators of erythrocyte survival do not correlate with acute vaso-occlusive crises in patients with sickle cell disease: a phase III randomized, placebo-controlled, double-blind study of the Gardos channel blocker senicapoc (ICA-17043). British Journal of Haematology 153(1): 92-104, 2011

A randomized, double-blind, crossover comparison of the efficacy and safety of oral controlled-release tramadol and placebo in patients with painful osteoarthritis. Pain Research and Management 13(2): 93-102, 2008

Dexamethasone therapy for children with acute chest syndrome complicating sickle cell disease A randomized, double-blind, placebo-controlled pilot study. Blood 86(10 SUPPL 1): 142A, 1995

Treatment of Painful Crises of Sickle Cell Disease. a Double Blind Study. Journal of Pediatrics 64: 132-133, 1964

Evaluation of the efficacy and safety of a Chinese herbal formula (RCM-106) for atopic dermatitis: study protocol for a randomised, double-blind, placebo-controlled trial in children. Bmj Open 3(12): E003906, 2014

Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study. Journal of Microbiology, Immunology, and Infection 50(5): 684-692, 2016

LB02: Randomized double-blind placebo controlled evaluation of the safety and efficacy of recombinant Antithrombin versus placebo in preterm preeclampsia. American Journal of Obstetrics and Gynecology 216(1): S559-S560, 2017

A double-blind, randomized, placebo/active controlled crossover evaluation of the efficacy and safety of Ritalin ® LA in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. Journal of Child and Adolescent Psychopharmacology 20(5): 377-385, 2011