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ID
Source
Health condition
Premedication in children scheduled for minor elective procedures such as inguinal hernia repair, circumcision and orchidopexy under general anaesthesia.
Keywords: premedication,children midazolam, dexmedetomidine
Sponsors and support
Sir Ganga Ram Hospital, New Delhi ,India
Sir Ganga Ram Hospital, New Delhi , India
Intervention
Outcome measures
Primary outcome
1. 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 outcome
Time to discharge from post-anaesthesia care unit (PACU).
Background summary
N/A
Study objective
One 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 ß2-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.
Study design
Time 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).
Intervention
Children 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 µg/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.
Sir Ganga Ram Hospital, New Delhi, India
Deepanjali Pant
New Delhi
India
deepanjalipant@gmail.com
Sir Ganga Ram Hospital, New Delhi, India
Deepanjali Pant
New Delhi
India
deepanjalipant@gmail.com
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2531 |
NTR-old | NTR2649 |
Other | : EC 09/10/171 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |