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

NCT ID: NCT03260439

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Tramadol - Anesthetics- Child - Circumcision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: OTHER

Tramadol

Intervention Type: 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.

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

Group Type: OTHER

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

group BT; group B or control

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leila mansali stambouli

OTHER

Sponsor Role: lead

Responsible Party

Leila mansali stambouli

Principal Investgator and ClinicalProfessor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

leila Mansali Stambouli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Fattouma Bourguiba Monastir TUNISIA

Locations

University Hospital of Fattouma Bourguiba

Monastir, Monastir- Tunisia, Tunisia

Countries

Tunisia

References

Kargi E, Isikdemir A, Tokgoz H, Erol B, Isikdemir F, Hanci V, Payasli C. Comparison of local anesthetic effects of tramadol with prilocaine during circumcision procedure. Urology. 2010 Mar;75(3):672-5. doi: 10.1016/j.urology.2009.06.108. Epub 2009 Oct 24.

Reference Type: BACKGROUND

PMID: 19854483 (View on PubMed)

Other Identifiers

OMB NO: 0925-0586

Identifier Type: -

Identifier Source: org_study_id