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

NCT03260439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2017-08-24

No results posted yet for this study

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.

Conditions

  • Tramadol - Anesthetics- Child - Circumcision

Interventions

DRUG

Tramadol

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.

DRUG

Placebo

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 & Collaborators

  • Leila mansali stambouli

    lead OTHER

Principal Investigators

  • leila Mansali Stambouli, MD PhD · University Hospital of Fattouma Bourguiba Monastir TUNISIA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Tunisia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260439 on ClinicalTrials.gov