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Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05444036
Enrollment
60
Registered
2022-07-05
Start date
2018-09-01
Completion date
2019-06-01
Last updated
2022-09-10

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

Conditions

Pediatric Surgery, Surgery

Keywords

Caudal bupivacaine, ketamine, anaesthesia, paediatric surgeries

Brief summary

Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Pain is a multidimensional, subjective, perceptual event having a variety of qualities such as intensity, quality, time course, and effects that are perceived differently by each person. Because the operational definition of pain necessitates self-report, pain experienced by children and babies is frequently overlooked, if not ignored. When general anesthesia is paired with regional procedures, children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics, leaving them nearly free of nausea, vomiting, itching, or unneeded drowsiness. Being completely awake and able to drink soon after surgery, as well as having no issues breathing even after lengthy surgery, are significant benefits that children and parents value.

Detailed description

Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent. Morphine, clonidine, ketamine, and midazolam were among the drugs used. Although peripheral nerve blocks and caudal anesthesia are relatively safe, extreme attention is required to minimize adverse consequences. Pediatric anesthesiologists must have adequate training to ensure patient safety. A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects (overdoses, intravenous administration induced seizures, tip displacement of epidural catheters or centrally located abscesses). Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and, as a result, lessen postoperative pain. It also has a peripheral analgesic effect. Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects.

Interventions

DRUGKetamine

compare caudal ketamine-bupivacaine against caudal bupivacaine-saline in paediatric Measuring pain in patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

comparing caudal block by bupivacaine with and without ketamine in paediatric patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties.

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

Inclusion criteria

1- All children whom were diagnosed with herniotomy, orchidopexy, or urethroplasty.

Exclusion criteria

1. Drugs used allergy or sensitivity, 2. contraindications to caudal injection, such as infection at the injection site, 3. bleeding disorders 4. caudal vertebral abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Post-operative Pain24-hour analgesic after surgeryAssessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026