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Analgesia in children with lower abdominal surgery

Comparing Magnesium Sulphate, Dexmedetomidine and Midazolam as adjuvant therapy to caudal Bupivacaine in postoperative analgesia in children undergoing lower abdominal surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240610062072N1
Enrollment
90
Registered
2024-06-22
Start date
2024-06-13
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Repair of rectal prolapse, undescended testis, hypospadias repair, orchiopexy, inguinal hernia, hemorrhoids.

Interventions

Intervention 1: Intervention group 1: Patients are under general anesthesia with caudal block. Induction of anesthesia is done by inhalation with sevoflurane and oxygen. After establishing the intrave

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: All children between the ages of 2 to 8 years who are candidates for lower abdominal surgery Children who are candidates for lower abdominal surgery who are electively referred to Valiasr, Amir al-Momenin and Amir Kabir hospitals. Patients with ASA Class I, II Duration of surgery between 30 and 90 minutes Absence of seizure history, heart, lung, kidney and genetic diseases in patients who are candidates for surgery Absence of diseases and mental disorders and mental and physical decline Informed consent from the child's parents to participate in the study must be taken No sensitivity to local anesthetics

Exclusion criteria

Exclusion criteria: Patients who care candidates for emergency lower abdominal surgery Patients who are candidates for a surgery that lasts more than 90 minutes. Patients who suffer cardio-respiratory arrest during surgery for any reason. Patients who undergo multiple puncture in the process of caudal block.

Design outcomes

Primary

MeasureTime frame
The amount of postoperative pain in children undergoing lower abdominal surgery, which is measured by the Visual Analog Scale self-scoring tool or the Children's Hospital of Eastern Ontario Pain Scale descriptive tool. Timepoint: The amount of pain is measured during recovery phase and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Visual Analogue Scale tool is used for self-reporting of pain intensity. This criterion is easy to understand, its probability of error is low, and its filling time is short. It is used in all age groups and it is very easy for children to understand because of the smiling faces. The simplest type of Visual Analogue Scale measurement system is a straight line, usually 100 mm long. The investigated variable, which is pain, is lowest on the left side and highest on the right side. No pain from 0 to 4 mm, mild pain from 5 to 44 mm, moderate pain from 45 to 74 and severe pain from 75 to 100 mm. The scale line must be shown to the patient because it is a visual measure; In other words, they should be asked to indicate the extent of his pain on the line. Children's Hospital of Eastern Ontario Pain Scale, which stands for Children's Hospital of Eastern Ontario Pain Scale, is used to evaluate pain. This instrument measures six categories of pain-related behaviors in children aged 1 to 7 years: crying, face, speech, touch, legs, and upper body. A time period of 5 seconds is allocated to observe the child's behavior and 25 seconds to record the answer and score. The coordination between the clinical decision to start analgesic treatment with the results obtained from the Children's Hospital of Eastern Ontario Pain Scale criteria has the most understanding among the pain measurement criteria.

Secondary

MeasureTime frame
Incidence of vomiting. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: A questionnaire designed for this study that raises the number of times shivering, vomiting, pain score and the degree of desire for extra analgesic and is filled by the intern.;Incidence of chills. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: A questionnaire designed for this study that raises the number of times shivering, vomiting, pain score and the degree of desire for extra analgesic and is filled by the intern.;Consumption of extra analgesic. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Ward notes.;Blood pressure. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Aneroid Sphygmomanometer or blood Pressure monitor.;Pulse rate. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Pulse oximeter.;Blood Oxygen Saturation. Timepoint: During recovery and then 2, 4, 8, 12 and 24 hours after the operation. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMitra Fazli

Arak University of Medical Sciences

mitrafazli99@gmail.com+98 86 3422 4635

Outcome results

None listed

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