AzTrials
AzTrials

Inguinal HerniaPhase 2NCT01701778

Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

A Phase 2 study testing Caudal Dexmedetomidine, Intravenous Dexmedetomidine and sevoflurane in people with Inguinal Hernia and Cryptorchidism, run by Yao Yusheng at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 5 years, men only
Conditions the study is for
Inguinal Hernia, Cryptorchidism
What is being tested?
Caudal Dexmedetomidine, Intravenous Dexmedetomidine and sevoflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
Oct 2012to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • ASA status I-II
  • aged 2-5 yr
  • Undergoing unilateral orchiopexy/inguinal hernia repair

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

Other trials in China

About this study

Official title: Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

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.

Read the detailed description

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.

Being tested
Caudal Dexmedetomidine, Intravenous Dexmedetomidine, Placebo, sevoflurane
Keywords
Dexmedetomidine, Postoperative pain reaction, anesthesia, children
Medical subject headings
Hernia, Inguinal, Cryptorchidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caudal DexmedetomidineDrug

    Also called Precedex

    Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

    Intravenous: 10 ml normal saline

  • Intravenous DexmedetomidineDrug

    Also called Precedex

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: dexmedetomidine 1µg/kg

  • PlaceboDrug

    Also called Levobupivacaine

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: 10 ml normal saline

  • sevofluraneDrug

    Induction and maintain anaesthesia

Study groups in NCT01701778
Study groupRoleWhat they receive
Caudal DexmedetomidineExperimentalCaudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Caudal Dexmedetomidine; Drug: sevoflurane
Intravenous DexmedetomidineExperimentalCaudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Intravenous Dexmedetomidine; Drug: sevoflurane
PlaceboPlacebo comparatorCaudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Placebo; Drug: sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first rescue medication

    the Children and Infants Postoperative Pain Scale (CHIPPS)

    Measured: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h

Secondary outcomes (6)

  1. the number of patients not requiring rescue analgesia

    the quality of postoperative pain control

    Measured: After surgery,up to 24h

  2. the sedation score

    sedation was assessed using the Modified Ramsay Sedation Score

    Measured: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h

  3. Residual motor block

    the degree of motor blockade was assessed using a modified Bromage scale

    Measured: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h

  4. the incidence of emergence agitation

    The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)

    Measured: Participants will be followed for the duration of PACU stay, an expected average of 2 hours

  5. side effects

    side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention

    Measured: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h

  6. Pain intensity

    Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)

    Measured: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701778
Sponsor's protocol ID
FujianPH
Other IDs
FujianPH-TRC-121002
Status last verified
Nov 2018
First submitted
2 Oct 2012
Last updated
15 Nov 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.

    PubMed 30302881

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caudal Dexmedetomidine, Intravenous Dexmedetomidine and sevoflurane in people with Inguinal Hernia and Cryptorchidism, run by Yao Yusheng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in