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

Tramadol - Anesthetics- Child - Circumcision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260439
• Other study ID #: OMB NO: 0925-0586
• Status: Completed
• Phase: N/A
• First received: August 18, 2017
• Last updated: August 21, 2017
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Tramadol - Anesthetics- Child - Circumcision

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	University Hospital of Fattouma Bourguiba	Monastir	Monastir- Tunisia

Sponsors (1)

Lead Sponsor	Collaborator
Leila mansali stambouli

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Kargi E, Isikdemir A, Tokgöz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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