The effect of dexmedetomidine in combination with local anaesthetics after application around nerves in the abdominal wall in pediatric patients.

• Conditions: Pediatric patients receive ilioinguinal-iliohypogastric nerve blockade with 0.2ml/kg ropivacaine 0.197% and 0.3µg/kg dexmedetomidine or 0.2ml/kg ropivacaine 0.197% and saline as a placebo. Aim of the study is to investigate if dexmedetomidine as an adjuvant to local anaesthetics prolongs the duration of the block and furthermore reduces the postoperative pain therapy or at least delay the first application of analgetic drugs.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-000122-60-SE
• Lead Sponsor: Karolinska University Hospital, Division of Pediatrics/Astrid Lindgren Children´s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Paediatric outpatients undergoing hernia operation
•Aged between 6months and 8 years
•Written informed consent given by parents/legal guardian after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Contraindication to a peripheral nerve block e.g. local skin infection at the site of nerve block injection, known allergy against local anaesthetics, severe coagulopathy, local anatomical abnormality
•Participation in another clinical study within the last 4 weeks prior to study
•Lack of parents´ cooperation and language difficulties
•Other objections to participate in the study in the opinion of the investigator
•BMI>30kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to investigate if paediatric patients could have a benefit from dexmedetomidine;Secondary Objective: Dexmedetomidine as an adjuvant to local anaesthetic reduces alterations in feeding and sleeping habits;Primary end point(s): Dexmedetomidine as an adjuvant to local anesthetic prolongs the duration of an ilioinguinal iliohypogastric nerve block in paediatric patients and reduces the need of postoperative pain therapy.;Timepoint(s) of evaluation of this end point: •3 hours postoperative in PACU by nurse<br>•6 hours postoperative at home by parents<br>•12 hours postoperative at home by parents<br>•24 hours postoperative at home by parents<br>•Sleeping interruption (if differs from daily routine)<br>•Denying of feeding<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Dexmedetomidine as an adjuvant to local anesthetic causes less alteration in daily routine relating to sleeping and feeding habits;Timepoint(s) of evaluation of this end point: •3 hours postoperative in PACU by nurse<br>•6 hours postoperative at home by parents<br>•12 hours postoperative at home by parents<br>•24 hours postoperative at home by parents<br>•Sleeping interruption (if differs from daily routine)<br>•Denying of feeding<br>