CLONidine and ROPivacaine in peripheral nerve blocks in children

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: Between January 2009 to May 2010, 77 consecutive children, American Society of Anesthesiologists (ASA) physical status I and II, aged 5‐14 years were scheduled for elective mild to moderate painful foot and ankle surgery. 66 children were randomly assigned to three groups by means of a computer generated table to receive either isotonic saline (n=21) or clonidine (n =23) or clonidine plus 0.2% ropivacaine (n=22), during performance of a sciatic lateral popliteal block (SLPB) plus femoral block. The investigators were blind to the group assignment. The placebo or the treatment solutions were prepared by the pharmacy and supplied to the Department of Anaesthesia in syringes labelled with predetermined code for each solution. There were two syringes for the SLPB and the femoral block respectively. In the SLPB, the syringes contained 1. For the control group isotonic saline 10 ml plus 0.25 ml/kg and saline 0.13 ml/kg 2. For the clonidine group isotonic saline 10 ml plus 0.25 ml/kg and clonidine 2 µg/kg (0.13 ml/kg) respectively 3. Finally in the clonidine plus 0.2% ropivacaine group the syringes contained 0.2% ropivacaine 10 ml plus 0.25 ml/kg (maximum 25 ml) and clonidine 2 µg/kg (0.13 ml/kg) respectively. Similarly in the femoral block the syringes contained 1. For the control group isotonic saline: 0.4 ml/kg and 0.065 ml/kg respectively 2. For the clonidine group isotonic saline 0.4 ml/kg and clonidine 1µg/kg (0.065 ml/kg) respectively 3. For clonidine plus 0.2% ropivacaine group 0.2% ropivacaine 0.4 ml/kg and clonidine 1µg/kg (0.065 ml/kg) respectively. The maximum dose of 0.2% ropivacaine was decided to be 3.5 mg/kg and for clonidine 3 µg/kg. In the anaesthetised children in the supine position, the SLPB was performed, using 100 mm or 50 mm, 21 gauge insulated stimulated needle. An additional femoral block became necessary for the use of tourniquet in the area around the thigh. After the performance of blocks a pneumatic tourniquet at 150 mmHg was applied CONDITION: Disturbances of Achilles tendon and club foot ; Musculoskeletal Diseases ; Disturbances of Achilles tendon and club foot PRIMARY OUTCOME: Time to first analgesic request of nalbuphine after the surgery by Kaplan‐ Meier analysis. Postoperative analgesia was assessed by means of a colour analogue scale (CAS). Pain CAS score at rest, was assessed in the recovery room (0), 2, 4, 6, 8, 18, 24 hours postoperatively and the tourniquet pain (0). Total number of rescue nalbuphine doses and the total amount of nalbuphine for the 24 hours observational period. SECONDARY OUTCOME: 1. Classification of motor and sensory block; 2. Restlessness based on dichotomous(yes or no); 3. Incidence of nausea and/or vomiting ; 4. Sedation level using a four‐point scale ; 5. Children?s parents satisfaction score was assessed on the second postoperative day, using a numerical scale. INCLUSION CRITERIA: 1. Children who underwent Achilles lengthening 2. Children with club foot
Epistemonikos ID: 4f6b306e1ce30c7ae8c62638f44461f54bf95e17
First added on: Aug 22, 2024