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

Leila mansali stambouli

Status: Completed

Conditions: Tramadol - Anesthetics- Child - Circumcision

Treatments: Drug: Tramadol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03260439

OMB NO: 0925-0586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups

G1 (group BT)

Other group

Description:

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

Treatment:

Drug: Tramadol

G2 (group B or control)

Other group

Description:

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

Treatment:

Drug: Placebo