Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
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| ClinicalTrials.gov Identifier: NCT01701778 |
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Recruitment Status :
Completed
First Posted : October 5, 2012
Last Update Posted : November 15, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Inguinal Hernia Cryptorchidism | Drug: Caudal Dexmedetomidine Drug: Intravenous Dexmedetomidine Drug: Placebo Drug: sevoflurane | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | January 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Caudal Dexmedetomidine
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
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Other Name: Precedex Drug: sevoflurane Induction and maintain anaesthesia |
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Experimental: Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane |
Drug: Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Other Name: Precedex Drug: sevoflurane Induction and maintain anaesthesia |
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Placebo Comparator: Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane |
Drug: Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Other Name: Levobupivacaine Drug: sevoflurane Induction and maintain anaesthesia |
- Time to first rescue medication [ Time Frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h ]the Children and Infants Postoperative Pain Scale (CHIPPS)
- the number of patients not requiring rescue analgesia [ Time Frame: After surgery,up to 24h ]the quality of postoperative pain control
- the sedation score [ Time Frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h ]sedation was assessed using the Modified Ramsay Sedation Score
- Residual motor block [ Time Frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h ]the degree of motor blockade was assessed using a modified Bromage scale
- the incidence of emergence agitation [ Time Frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours ]The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
- side effects [ Time Frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h ]side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
- Pain intensity [ Time Frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h ]Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
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| Ages Eligible for Study: | 2 Years to 5 Years (Child) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA status I-II
- aged 2-5 yr
- Undergoing unilateral orchiopexy/inguinal hernia repair
Exclusion Criteria:
- Hypersensitivity to any local anesthetics
- Patient has history of allergy, intolerance, or reaction to dexmedetomidine
- Infections at puncture sites
- Bleeding diathesis
- Preexisting neurological disease
- Diabetes mellitus
- Children with uncorrected cardiac lesions
- Children with heart block or liver impairment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701778
| China, Fujian | |
| Fujian Provincial Hospital | |
| Fuzhou, Fujian, China, 350001 | |
| Principal Investigator: | Yusheng Yao, M.D. | Fujian Provincial Hospital | |
| Principal Investigator: | Yanqing Chen, M.D. | Fujian Provicial Hospital | |
| Study Director: | Jin Liu, M.D. | West China Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yao Yusheng, Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children, Fujian Provincial Hospital |
| ClinicalTrials.gov Identifier: | NCT01701778 |
| Other Study ID Numbers: |
FujianPH FujianPH-TRC-121002 ( Registry Identifier: Fujian Provicial Hospital ) |
| First Posted: | October 5, 2012 Key Record Dates |
| Last Update Posted: | November 15, 2018 |
| Last Verified: | November 2018 |
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Dexmedetomidine Postoperative pain reaction anesthesia children |
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Cryptorchidism Hernia, Inguinal Hernia Pathological Conditions, Anatomical Hernia, Abdominal Testicular Diseases Urogenital Abnormalities Congenital Abnormalities Gonadal Disorders Endocrine System Diseases Dexmedetomidine Sevoflurane Levobupivacaine Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Anesthetics, Inhalation Anesthetics, General Anesthetics |