PAF Hospital Islamabad
Islamabad, Capital, 44000, Pakistan
NCT Number: NCT07626255
The goal of this clinical trial(Quasi Experimental) is to compare efficacy of oral midazolam over intra-muscular Midazolam in children suffering from seizures. The main question it aims to answer is:
Does Buccal midazolam has a better efficacy as compared to intramuscular midazolam in children presenting with seizures?
There will be two groups determined by randomisation and then one will be given buccal midazolam and other will will be administered IM Midazolam .The out come will be determined by the determining the cessation of seizures within 5 minutes duration achieved by administration of drug.
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Notify Me6 month–12 year
All sexes
Interventional
Phase 4
Islamabad, Capital, 44000, Pakistan
Generalised convulsive seizure is a serious and potentially life threatening medical emergency that requires prompt intervention. Administration of buccal midazolam is an efficient and easier method for control of seizures without the need for intravenous cannulation expertise or intramuscular injections.
To compare the outcome of buccal midazolam versus intramuscular midazolam in children presenting with seizures.
It is RCT
Pediatric Medicine Department, PAF hospital, Islamabad
15th January 2022 to 14th July 2022
All the patients were divided into two groups by lottery method.
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml).
In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml). They were followed till resolution of symptoms. If seizure resolved within 5 minutes, then success was labelled.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In group A, children were given intramuscular midazolam in the thigh at 0.05 ml/kg (maximum 1.6 ml). In group B, children were given buccal midazolam at 0.06 ml/kg (maximum 2 ml).
Time frame: 5 minutes after drug administered
Cessation of seizures within 5 minutes duration achieved by administration of drug will be determined as success. Based on this cut off value for time we obtained dichotomous results i.e, Successful or Not Successful.
Pakistan Air Force (PAF) Hospital Islamabad
Other
Comparison of Buccal Midazolam Versus Inter-muscular Midazolam in Control of Seizures
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