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PainPhase 2NCT02416063

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

A Phase 2 study testing Caudal Dexmedetomidine and Intravenous dexmedetomidine in people with Pain, run by University of Jordan.

Completed

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

Official record
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Trial summary

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery. Read more about this study

Who is it for?
Ages 1 year to 6 years
Conditions the study is for
Pain
What is being tested?
Caudal Dexmedetomidine and Intravenous dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
No sites listed yet
Study dates
Jan 2014to Oct 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 1 year to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients with American Society of Anesthesiologists (ASA) - I
  • Scheduled for lower abdominal and perineal surgery
  • Under general anesthesia

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
  • Children with uncorrected cardiac lesions
  • Children with heart block

About this study

Official title: Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

Read the detailed description

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 dexmedetomidine 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 bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery 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 B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous

Conditions
Pain
Being tested
Caudal Dexmedetomidine, Intravenous dexmedetomidine, Placebo
Medical subject headings
Pain

What participants receive

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

  • Caudal DexmedetomidineDrug

    Also called dexmedetomidine, Precedex

    Drug:Caudal bupivacaine 0.25% 1ml/kg

    Drug: Caudal dexmedetomidine 1µg/kg

    Intravenous: 10 ml normal saline

    sevoflurane Induction and maintenance of anesthesia

  • Intravenous dexmedetomidineDrug

    Also called precedex

    Drug:Caudal bupivacaine 0.25% 1ml/kg.

    Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml

    sevoflurane Induction and maintenance of anesthesia

  • PlaceboDrug

    Also called normal saline

    Drug:Caudal bupivacaine 0.25% 1ml/kg

    Intravenous: Normal saline 10 ml

    sevoflurane Induction and maintenance of anesthesia

Study groups in NCT02416063
Study groupRoleWhat they receive
caudal DexmedetomidineActive comparatorDrug:Caudal Bupivacaine 0.25% 1ml/kg . Drug:caudal Dexmedetomidine 1μg /kg. Intravenous :10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Caudal Dexmedetomidine
Intravenous DexmedetomidineActive comparatorDrug:Caudal bupivacaine 0.25% 1ml/kg Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Intravenous dexmedetomidine
PlaceboPlacebo comparatorCaudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane
Receives: Drug: Placebo

What is being measured

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

  1. Time to first analgesic requirement

    Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4

    Measured: 24 hours

Secondary outcomes (7)

  1. Postoperative behaviour scores

    behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.

    Measured: 2 hours

  2. Sevoflurane concentration

    Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60

    Measured: 1 hour

  3. Blood pressure Perioperative blood pressure readings

    Perioperative blood pressure readings

    Measured: 2 hours

  4. Heart Rate

    Perioperative heart rate readings

    Measured: 2 hours

  5. the incidence of emergence agitation

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

    Measured: 2 hours

  6. Postoperative pain scores

    postoperative pain score will be assessed over 24 hours

    Measured: 24 hours

  7. Side effects

    side effects including nausea, vomiting and urinary retention and lower limb weakness

    Measured: 24 hours

Timeline

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

  1. First posted14 Apr 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2014
  4. Study completionOct 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02416063
Sponsor's protocol ID
Faculty of medicine-JU
Status last verified
Apr 2015
First submitted
12 Mar 2015
Last updated
14 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014.

    PubMed 24932765

  • Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.

    PubMed 16101707

  • Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf.

    PubMed 19952754

  • Kim NY, Kim SY, Yoon HJ, Kil HK. Effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery. Yonsei Med J. 2014 Jan;55(1):209-15. doi: 10.3349/ymj.2014.55.1.209.

    PubMed 24339309

  • She YJ, Xie GT, Tan YH, Kuang XH, Yu GF, Lian GH, Song XR. A prospective study comparing the onset and analgesic efficacy of different concentrations of levobupivacaine with/without dexmedetomidine in young children undergoing caudal blockade. J Clin Anesth. 2015 Feb;27(1):17-22. doi: 10.1016/j.jclinane.2014.09.005. Epub 2014 Nov 21.

    PubMed 25468576

  • Schnabel A, Reichl SU, Poepping DM, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of intraoperative dexmedetomidine for acute postoperative pain in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2013 Feb;23(2):170-9. doi: 10.1111/pan.12030. Epub 2012 Oct 9.

    PubMed 23043461

  • Fares KM, Othman AH, Alieldin NH. Efficacy and safety of dexmedetomidine added to caudal bupivacaine in pediatric major abdominal cancer surgery. Pain Physician. 2014 Sep-Oct;17(5):393-400.

    PubMed 25247897

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caudal Dexmedetomidine and Intravenous dexmedetomidine in people with Pain, run by University of Jordan.

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 7 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

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 analgesic requirement (time frame: 24 hours). 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 NCT02416063, which also lists 7 linked publications.

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 14 Apr 2015.

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