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

NCT03260439 | Completed DMC

• 1 other identifier: OMB NO: 0925-0586
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Tramadol - Anesthetics- Child - Circumcision

Keywords

tramadol-penile block -circumcision surgery-anesthesia-child

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

G1 (group BT)

OTHER

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

G2 (group B or control)

OTHER

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

Interventions

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.

Also known as: group BT

G1 (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.

Also known as: group B or control

G2 (group B or control)

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I or II
• Were scheudled to circumcision surgery
• Performed by experenced surgeon under general anesthesia

You may not qualify if:

• children with full stomach
• A history of gastric reflux
• A history of cardiovascular or neuromuscular disease
• Allergies to the study drugs

Sponsors & Collaborators

• Leila mansali stambouli: lead

Study Sites (1)

University Hospital of Fattouma Bourguiba

Monastir, Monastir- Tunisia, 5000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 19854483 BACKGROUND

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• leila Mansali Stambouli, MD PhD

  University Hospital of Fattouma Bourguiba Monastir TUNISIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investgator and ClinicalProfessor

Model Details: Randomized, controlled and double blind assignment

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 24, 2017
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)