Tramadol - Anesthetics- Child - Circumcision
Conditions
Keywords
tramadol-penile block -circumcision surgery-anesthesia-child
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.
Interventions
DRUGTramadol
Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Postoperativ 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 The hospital and home, and by the time of the first demand analgesic.
DRUGPlacebo
Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Postoperativ 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 The hospital and home, and by the time of the first demand analgesic.
Sponsors
Leila mansali stambouli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, controlled and double blind assignment
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I or II * Were scheudled to circumcision surgery * Performed by experenced surgeon under general anesthesia
Exclusion criteria
* children with full stomach * A history of gastric reflux * A history of cardiovascular or neuromuscular disease * Allergies to the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Tunisia
Outcome results
None listed