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adding dexmedetomidine and neostigmine and midazolam to bupivacaine 0.25% in management postoperative pain by caudal anesthesia

Comparison of adding dexmedetomidine and neostigmine and midazolam to bupivacaine 0.25% in management postoperative pain in lower abdominal surgeries in children by caudal anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230124057200N1
Enrollment
120
Registered
2023-02-03
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Condition 1: Diverticular disease. Condition 2: lower abdominal surgeries. Condition 3: appendicitis. Condition 4: Inguinal hernias. Condition 5: hypospadias. Condition 6: Undescended testicle. Condition 7: Intussusception. Condition 8: Volvulus. Condition 9: intestinal obstruction. Condition 10: caudal anesthesia. Diverticular disease of intestine Acute appendicitis Inguinal hernia Hypospadias Undescended and ectopic testicle Intussusception Volvulus Other impaction of intestine

Interventions

Intervention 1: First Intervention group: Bupivacaine 0.25% (Elixir Pharmaceuticals-Iran) in the amount of 0.5 ml per kilogram along with midazolam (Elixir Pharmaceuticals-Iran) in the amount of 50 mi

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: All children 2-8 years old (patients) candidates for lower abdominal surgery referring to Valiasr Hospital ASA Class I, II patients Patients whose surgery duration is between 45-90 minutes

Exclusion criteria

Exclusion criteria: All patients with underlying diseases of the heart, lungs, liver, etc. History of seizures Allergy to the drugs used in the study Patients in whom the caudal block cannot be performed

Design outcomes

Primary

MeasureTime frame
Pain level. Timepoint: during recovery after surgery and 1, 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: CHEOPS Criteria.

Secondary

MeasureTime frame
Average analgesic consumption. Timepoint: Within 24 hours after surgery. Method of measurement: patient file.;Mean arterial blood pressure. Timepoint: Every 15 minutes during surgery. Method of measurement: Mercury sphygmomanometer.;Pulse rate. Timepoint: Every 15 minutes during surgery. Method of measurement: pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Kasravi

Arak University of Medical Sciences

mohammadkasravi96@gmail.com+98 21 2272 8756

Outcome results

None listed

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