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.
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexmedetomidine
Product Code: EU/1/11/718/001
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 1
Sponsors
Karolinska University Hospital, Division of Pediatrics/Astrid Lindgren Children´s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 •6 hours postoperative at home by parents •12 hours postoperative at home by parents •24 hours postoperative at home by parents •Sleeping interruption (if differs from daily routine) •Denying of feeding | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 •6 hours postoperative at home by parents •12 hours postoperative at home by parents •24 hours postoperative at home by parents •Sleeping interruption (if differs from daily routine) •Denying of feeding | — |
Countries
Sweden
Contacts
Public ContactMärit Lundblad
Karolinska University Hospital, Division of Pediatrics/Astrid Lindgren Children´s Hospital
Outcome results
None listed