Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

NCT05444036 | Completed Phase 1 DMC

• 1 other identifier: NIRVANA 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Pediatric Surgery

Keywords

Caudal bupivacaine; ketamine; anaesthesia; paediatric surgeries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ketamin-bupivacaine Group

EXPERIMENTAL

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

Drug: Ketamine

bupivacaine-saline Group

EXPERIMENTAL

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

Drug: Ketamine

Interventions

Ketamine 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

Ketamin-bupivacaine Group; bupivacaine-saline Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Drugs used allergy or sensitivity,
• contraindications to caudal injection, such as infection at the injection site,
• bleeding disorders
• caudal vertebral abnormalities

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

October 6 University Hospital

Giza, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nirvana Elshalakany, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: June 1, 2019
• Last Updated: September 10, 2022

Record last verified: 2022-06

Locations

EG (1)