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Completed

NCT Number: NCT07140627

COMPARISON OF BUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN CAUDAL BLOCK AMONG CHILDREN UNDERGOING INGUINAL HERNIOTOMY

A random controlled trial, was held at Jinnah Hospital in Lahore, consisting of 60 male pediatrics (6 months to 12 years), who were undergoing unilateral inguinal herniotomy or hydrocele repair. Patients were randomly allocated in two groups: Group A alone received 1 mL/kg 0.25% bupivacaine, while Group B received the same dose with 1 μg/kg dexmedetomidine. The pain score was evaluated by Wong-Beker Face Scale postoperatively every two hours, rescue analgesia (intravenous paracetamol 10 mg/kg) when the pain score reached ≥4

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rescue Analgesia Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Allama Iqbal Medical College/ Jinnah Hospital Lahore

Lahore, Punjab Province, 54550, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male children who were undergoing elective unilateral inguinal herniotomy or hydrocele surgery

Exclusion criteria

  • Patients were excluded if they were already on analgesic (according to medical records)
  • Obstructed inguinal hernias or bilateral hernias (confirmed through ultrasound)

Treatment and study plan

Bupivacain

Drug

A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants had received 1 mL/kg 0.25% bupivacaine. Post operative pain was assessed.

Dexmedetomidine & Bupivacaine.

Drug

A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants were included and administered 1 mL/kg 0.25% bupivacaine and 1 μg/kg dexmedetomidine. Post operative pain was assessed.

Primary outcomes

  1. Post operative Pain

    Time frame: 2 hourly assessment for 8 hours on basis of pain score

    In both groups the attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.

Sponsors and collaborators

Lead sponsor

Allama Iqbal Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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