Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision
- Conditions
- Tramadol - Anesthetics- Child - Circumcision
- Interventions
- Drug: Placebo
- Registration Number
- NCT03260439
- Lead Sponsor
- Leila mansali stambouli
- Brief Summary
After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We collected 53 children in each group.
- Detailed Description
After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision. Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or saline serum at the same volume (G2: Group B or control). Postoperative analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic inThe hospital and at home, and by the time of the first demand analgesic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- ASA physical status I or II
- Were scheudled to circumcision surgery
- Performed by experenced surgeon under general anesthesia
- children with full stomach
- A history of gastric reflux
- A history of cardiovascular or neuromuscular disease
- Allergies to the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G2 (group B or control) Placebo The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Placebo G1 (group BT) Tramadol The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Tramadol
- Primary Outcome Measures
Name Time Method Postoperative analgesia from awake until 60 min after emergence Postoperative analgesia was assessed by modified OPS scale, by the number of the
number of analgesic in The hospital and home, and by the time of the first demand analgesic.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital of Fattouma Bourguiba
🇹🇳Monastir, Monastir- Tunisia, Tunisia
University Hospital of Fattouma Bourguiba🇹🇳Monastir, Monastir- Tunisia, Tunisia