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Completed

NCT Number: NCT05444036

Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

October 6 University Hospital

Giza, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Measurement of Post-operative Pain

    Time frame: 24-hour analgesic after surgery

    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).

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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