Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

NCT ID: NCT05444036

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-06-01

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.

Conditions

Surgery; Pediatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketamin-bupivacaine Group

in this method,30 patients which received 0.5 mg/kg of preservative free ketamine (i.e. 0.05ml/kg of 10mg/ml ketamine diluted up to 1ml in normal saline) plus1ml/kg of 0.25 % bupivacaine caudally, after induction of general anaesthesia

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

bupivacaine-saline Group

30 patients received 1ml/kg of 0.25 % bupivacaine plus 1ml of normal saline caudally of just after induction of general anaesthesia, just after induction of general anaesthesia

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirvana Elshalakany, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

Locations

October 6 University Hospital

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

NIRVANA 2

Identifier Type: -

Identifier Source: org_study_id