EUCTR2008-007996-26-IT
Active, not recruiting
Not Applicable
Comparison between wound infiltration with different ropivacaine concentrations following inguinal herniotomy for postoperative analgesia in children: a randomized, double-blind, placebo-controlled study. - Wound infiltration with different ropivacaine concentrations in children
ISTITUTO PER L`INFANZIA BURLO GAROFOLO0 sitesDecember 17, 2008
ConditionsChildren ASA 1-2, aged 1 to 8 years.MedDRA version: 9.1Level: LLTClassification code 10021945Term: Infiltration anaesthesia
DrugsNAROPINA 2MG/ML
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Children ASA 1-2, aged 1 to 8 years.
- Sponsor
- ISTITUTO PER L`INFANZIA BURLO GAROFOLO
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Randomized, double\-blind, placebo\-controlled study. 90 children, ASA 1\-2, aged 1 to 8 years, undergoing inguinal hernia repair under spinal anesthesia and light general anesthesia will be placed into 3 groups. The randomization will be organized at a central level (Epidemiology and Biostatistics Service, IRCCS Burlo Garofolo, Trieste) using a computer\-generated list. An adequate hidden of the generated sequences will be guaranteed by the use of sealed, opaque and consecutively numbered envelopes containing the description of the therapy assigned by the randomization process. The envelopes will be opened by nurses who will prepare the syringes containing the drug at different dilutions. In this way the patient and the operator who will apply wound infiltration and the trained postoperative pain evaluator will be blind in respect to the solution administered. The results will be collected using a specific form and subsequently collected and processed at a central level (Epidemiology and Biostatistics Service, IRCCS Burlo Garofolo, Trieste).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Children who have neurological, neuromuscular, psychiatric, convulsive or blood clotting disorders or any drug allergy will be excluded from the study.
Outcomes
Primary Outcomes
Not specified
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