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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Doses Tramadol With Bupivacaine in Penial Block Improve Efficiency of Postoperative Analgésia in Children in Circumcision

Conditions
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Tramadol - Anesthetics- Child - Circumcision

Intervention / Treatment
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* Drug: Tramadol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled and double blind assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G1 (group BT)<br>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 | Drug: Tramadol<br>* 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.<br>* Other names: group BT;|
| Other: G2 (group B or control)<br>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 | Drug: Placebo<br>* 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.<br>* Other names: group B or control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from awake until 60 min after emergence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tramadol-penile block -circumcision surgery-anesthesia-child