Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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HaliImekamilika

Wadhamini

University of Malawi College of Medicine

JARIBIO LA KLINIKI: NCT00116064

BioSeek: nct00116064

Maneno muhimu

Kikemikali

The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.

Maelezo

The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.

Tarehe

Imethibitishwa Mwisho:	05/31/2005
Iliyowasilishwa Kwanza:	06/25/2005
Uandikishaji uliokadiriwa Uliwasilishwa:	06/25/2005
Iliyotumwa Kwanza:	06/26/2005
Sasisho la Mwisho Liliwasilishwa:	07/19/2006
Sasisho la Mwisho Lilichapishwa:	07/20/2006
Tarehe halisi ya kuanza kwa masomo:	06/30/2004
Tarehe ya Kukamilisha Utafiti:	05/31/2005

Hali au ugonjwa

Status Epilepticus

Convulsions

Uingiliaji / matibabu

Drug: intranasal lorazepam

Drug: intramuscular paraldehyde

Awamu

Awamu 3

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	2 Months Kwa 2 Months
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - Children aged between 2 months and 12 years - Presenting with generalised convulsions Exclusion Criteria: - Any child who had received an anticonvulsant agent within 1 hour of presentation - Seizure stopped with rapid cooling or treatment of hypoglycaemia - Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy

Matokeo

Hatua za Matokeo ya Msingi

1. whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration [undefined]

Hatua za Matokeo ya Sekondari

1. time from drug administration to cessation of convulsion [undefined]

2. frequency of episodes requiring 2 or more anticonvulsant agents [undefined]

3. continuous blood pressure and oxygen saturation for 30 minutes post drug administration [undefined]

4. seizure recurrence within 24 hours of cessation of presenting convulsion [undefined]

5. survival/death [undefined]