Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444036
• Other study ID #: NIRVANA 2
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2022
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Surgery
• Surgery

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	October 6 University Hospital	Giza	CAiro

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Post-operative Pain	Assessment 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).	24-hour analgesic after surgery