Clinical trial NCT05444036: Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
Official title: Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgery
Pediatric Surgery
Keywords: Caudal bupivacaine
ketamine
anaesthesia
paediatric surgeries
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 60
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Post-operative Pain
timeFrame: 24-hour analgesic after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University Hospital
state: CAiro
Study officials:
affiliation: Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
name: Nirvana Elshalakany, Professor
role: PRINCIPAL_INVESTIGATOR
References: