Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision

Leila mansali stambouli106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

106

Conditions

Tramadol - Anesthetics- Child - Circumcision

Interventions

TramadolDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Fattouma Bourguiba

Monastir, Monastir- Tunisia, Tunisia

Outcomes

Primary Outcomes

Postoperative analgesia

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.

Time frame: from awake until 60 min after emergence

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.