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Comparison of Sublingual Midazolam and Dexmedetomidine for Premedication in Children.


- candidate number8760
- NTR NumberNTR2649
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2010
- Secondary IDsEC 09/10/171 
- Public TitleComparison of Sublingual Midazolam and Dexmedetomidine for Premedication in Children.
- Scientific TitleComparison of Sublingual Midazolam and Dexmedetomidine for Premedication in Children.
- ACRONYM
- hypothesisOne of the challenges in paediatric anaesthesia is to minimize distress for children in the operating room environment and to facilitate a smooth induction of anaesthesia. Pre-anaesthetic medication reduces the risk of adverse psychological and physiological sequelae of anaesthesia induction in a distressed child. Midazolam is the most commonly used drug for this purpose. Undesirable effects of midazolam such as restlessness, paradoxical reaction and negative postoperative behavioural changes have made it less than an ideal premedication. Dexmedetomidine is a potent, specific and selective 2-adrenoceptor agonist. It not only produces sedation but also produces anxiolysis, analgesia and decreased activity of sympathetic nervous system. It does not depress respiratory drive. Pharmacological sedation produced by dexmedetomidine mimics natural sleep, making it a promising agent for paediatric sedation. Because of the unique pharmacological properties of dexmedetomidine we hypothesize that dexmedotomidine may prove to be a better drug for premedication in children as compared to midazolam.
- Healt Condition(s) or Problem(s) studiedChildren, Midazolam, Premedication, Dexmedetomidine
- Inclusion criteria1. Children with ASA physical status I or II;
2. Age between 1 and 12 years;
3. Children undergoing elective inguinall hernia repair, orchidopexy or circumcision, under general anaesthesia and caudal block.
- Exclusion criteria1. Known allergy or hypersensitive reaction to midazolam or dexmedetomidine;
2. Liver or renal dysfunction;
3. Cardiac arrhythmia or congenital heart disease;
4. Mental retardation;
5. Use of enzyme inducing medication e.g. phenobarbitone;
6. Upper respiratory tract infection.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2010
- planned closingdate
- Target number of participants100
- InterventionsChildren will be randomly allocated into two groups:
1. Group I - 0.25 mg/kg midazolam will be given sublingually (drug to be retained in the mouth without spitting or swallowing) by asking the child to place the tip of the tongue to the back of upper teeth. The medication will be given atleast 20 minutes before induction of anaesthesia;
2. Group II- 1.5 g/kg dexmedetomidine will be given sublingually (drug to be retained in the mouth without spitting or swallowing) by asking the child to place the tip of the tongue to the back of upper teeth. The medication will be given approximately 45 minutes before induction of anaesthesia.
- Primary outcome1. Behaviour and sedation status of the child during separation from the parent and at induction of anaesthesia;
2. Mask acceptability of the child at induction of anaesthesia;
3. Perioperative changes in heart rate and blood pressure;
4. Behaviour status of the child at time of wake up from anaesthesia.
- Secondary outcomeTime to discharge from post-anaesthesia care unit (PACU).
- TimepointsTime at which the child enters the preoperative suite to the time at which the child is discharged from the post-anaesthesia care unit (also include the duration of anaesthesia).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Deepanjali Pant
- CONTACT for SCIENTIFIC QUERIESDr. Nitin Sethi
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Dept of Anaesthesiology, Pain & Perioperative Medicine Sir Ganga Ram Hospital, New Delhi, India
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-dec-2010 - 27-dec-2010


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