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

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ClinicalTrials.gov Identifier: NCT03260439
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Leila mansali stambouli, University of Monastir

Brief 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.

Condition or disease Intervention/treatment Phase
Tramadol - Anesthetics- Child - Circumcision Drug: Tramadol Drug: Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled and double blind assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Doses Tramadol With Bupivacaine in Penial Block Improve Efficiency of Postoperative Analgésia in Children in Circumcision
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
G1 (group BT)
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
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 Name: group BT

G2 (group B or control)
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
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 Name: group B or control




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260439


Locations
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Tunisia
University Hospital of Fattouma Bourguiba
Monastir, Monastir- Tunisia, Tunisia, 5000
Sponsors and Collaborators
Leila mansali stambouli
Investigators
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Principal Investigator: leila Mansali Stambouli, MD PhD University Hospital of Fattouma Bourguiba Monastir TUNISIA

Publications:
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Responsible Party: Leila mansali stambouli, Principal Investgator and ClinicalProfessor, University of Monastir
ClinicalTrials.gov Identifier: NCT03260439     History of Changes
Other Study ID Numbers: OMB NO: 0925-0586
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Leila mansali stambouli, University of Monastir:
tramadol-penile block -circumcision surgery-anesthesia-child
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents