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Comparing the effect of three local anesthesia drug regimes Bupivacaine, Bupivacaine-dexmedetomidine and Bupivacaine – fentanyl through an injection through the tail portion of the spinal column for providing postoperative analgesia in children one to five years old in a children's hospital.

The Comparison of Bupivacaine, Bupivacaine-dexmedetomidine and Bupivacaine – fentanyl by caudal technique for postoperative analgesia in children 1-5 years old in pediatric hospital.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015110318091N6
Enrollment
60
Registered
2016-01-23
Start date
2015-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in children. Inguinal hernia

Interventions

Intervention 1: First group (bupivacaine) which included 1 milliliter/kilogram from a solution of 0.25% buupivacaine which was prepared by adding distilled water to 0.5% bupivacaine with equal volumes
Prevention
First group (bupivacaine) which included 1 milliliter/kilogram from a solution of 0.25% buupivacaine which was prepared by adding distilled water to 0.5% bupivacaine with equal volumes.
Second group (bupivacaine-dexmedetomidine) which included 1 milliliter/kilogram from a solution of 0.25% bupivacaine which was prepared by adding distilled water to 0.5% bupivacaine and 2 microgram/ki
Third group (bupivacaine-fentanyl) which included 1 milliliter/kilogram from a solution of 0.25% bupivacaine which was prepared by adding distilled water to 0.5% bupivacaine and 2 microgram/kilogram f

Sponsors

Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children aged 1-5 years old; elective inguinal hernia operations. Exclusion criteria: cardiac-pulmonary congenital anomalies; history of drug allergy to the drugs used; contraindications to caudal block; cases with ASA class > I.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: at time points of 30 and 60 minutes after operation in recovery room and at 1st, 2nd, 4th, 6th, 12th and 24th hours after operation in the surgery unit. Method of measurement: Face Pain Scale Revise (FPS-R).

Secondary

MeasureTime frame
Heart rate. Timepoint: Every 10 minute after caudal block till and every 5 minute. Method of measurement: Anesthesia electrocardioraphic monitoring equipment.;Arterial oxygen saturation. Timepoint: 10 minutes after caudal block till the start of operation and with 5 minute intervals till the end of operation. Method of measurement: Pulse oximeter device.;Arterial blood pressure. Timepoint: Every 10 minute after caudal block till and every 5 minute. Method of measurement: No ninvasive blood pressure monitoring device.;Sedation. Timepoint: At 30 and 60 minutes after operation in the recovery room and at the 1st, 2nd, 4th, 6th, 12th and 24th hours time points. Method of measurement: Michigan University Sedation Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHashem Jarineshin

Hormozgan University of Medical Sciences

hjarineshin@yahoo.com+98 76 3334 5009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026