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Completed

NCT Number: NCT03260439

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

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.

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Fattouma Bourguiba

Monastir, Monastir- Tunisia, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

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.

Other names: group BT

Placebo

Drug

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.

Other names: group B or control

Primary outcomes

  1. Postoperative analgesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Leila mansali stambouli

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2017
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.