A Phase 2 interventional study of Caudal Dexmedetomidine and Intravenous Dexmedetomidine in Inguinal Hernia and Cryptorchidism, sponsored by Yao Yusheng. Completed at 1 site in China. Open to male participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by Yao Yusheng · Phase 2, Interventional, and Supportive care
The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.
Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of clonidine is the most beneficial remains unknown.
The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.
90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 90 is close to the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Yao Yusheng is the lead sponsor of 2 studies on the registry; none are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Drug: Caudal Dexmedetomidine · Drug: sevoflurane
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane
Drug: Intravenous Dexmedetomidine · Drug: sevoflurane
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Drug: Placebo · Drug: sevoflurane
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline
Also known as: Precedex
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg
Also known as: Precedex
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline
Also known as: Levobupivacaine
Induction and maintain anaesthesia
Time to first rescue medication
the Children and Infants Postoperative Pain Scale (CHIPPS)
Time frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h
the number of patients not requiring rescue analgesia
the quality of postoperative pain control
Time frame: After surgery,up to 24h
the sedation score
sedation was assessed using the Modified Ramsay Sedation Score
Time frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
Residual motor block
the degree of motor blockade was assessed using a modified Bromage scale
Time frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
the incidence of emergence agitation
The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
Time frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours
side effects
side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
Time frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
Pain intensity
Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
Time frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Yao Yusheng