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Pain, PostoperativePhase 2/3NCT02385435

Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children

A Phase 2/3 study testing Bupivacaine, dexmedetomidine 1μg.kg-1 and dexmedetomidine 2μg.kg-1 in people with Pain, Postoperative, 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 two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia 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, Postoperative
What is being tested?
Bupivacaine, dexmedetomidine 1μg.kg-1 and dexmedetomidine 2μg.kg-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
No sites listed yet
Study dates
Jan 2014to Aug 2014
Phase
Phase 2/3
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

  • history of developmental delay or mental retardation
  • known or suspected coagulopathy or recent use of anticoagulant/antiplatelet drugs.
  • known allergy to any of the study drugs.
  • any signs of infection or congenital abnormalities at the site of the proposed caudal block

About this study

Official title: Comparison of Caudal Bupivacaine Alone With Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Infra-umbilical Surgery: A Randomized Controlled Double Blinded Study

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children undergoing infra-umbilical surgery.

Read the detailed description
  • Quality assurance plan for data validation and registry: After Data was registered, it was reviewed by a second person who compared it to the Data in patient data collection forms.
  • Data check: carried out using Statistical Package for the Social Sciences (SPSS) variable definition protocols. Also data were entered in EXCEL sheets for comparisons to guarantee consistency.
  • Source data verification: Paper case report forms and medical records.
  • Standard Operating Procedures to address registry operations and analysis activities: Eligible patients were recruited after obtaining consent. Data was collected by qualified personnel rained on the process. Data was entered into Excel sheets and SPSS programs and compared for consistency. Analysis of Data was carried out by a qualified statistician. Adverse events were reported as yes/no variables. Data of patients who had Change in management was omitted from analysis.
  • Sample size assessment: Sample size was calculated to detect a 65% reduction in the analgesic requirement during the first 24 h from 75% in the bupivacaine group with α= 0.05 and β=0.80.
  • Plan for missing data: Patients with missing Data were omitted from statistical analysis.
  • Statistical analysis plan: carried out using International Business Machines (IBM) statistics 19.0 statistical package for windows. Data were compared using analysis of variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test for categorical ones. Post hoc analyses were carried out as appropriate.
Being tested
Bupivacaine, dexmedetomidine 1μg.kg-1, dexmedetomidine 2μg.kg-1
Keywords
caudal block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • BupivacaineDrug

    Also called Broup B

    Caudal Bupivacaine 2 mg/kg single shot

  • dexmedetomidine 1μg.kg-1Drug

    Also called Group BD1

    Caudal dexmedetomidine 1μg.kg-1, single shot

  • dexmedetomidine 2μg.kg-1Drug

    Also called Group BD2

    Caudal dexmedetomidine 2μg.kg-1, single shot

Study groups in NCT02385435
Study groupRoleWhat they receive
BupivacaineActive comparatorsingle shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
Receives: Drug: Bupivacaine
dexmedetomidine 1μg.kg-1Active comparatorSingle shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention
Receives: Drug: dexmedetomidine 1μg.kg-1
dexmedetomidine 2μg.kg-1Active comparatorSingle shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention
Receives: Drug: dexmedetomidine 2μg.kg-1

What is being measured

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

  1. Time to first analgesic requirement

    The time from end of surgery to the first requirement of postoperative analgesia

    Measured: 24 hours

  2. Postoperative pain scores

    Measured: 24 hours

  3. Number of postoperative analgesia doses

    Number of paracetamol doses needed by each patient

    Measured: 24 hours

Secondary outcomes (5)

  1. Postoperative sedation scores

    Level of sedation 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: intraoperative

  3. Blood pressure

    Intraoperative blood pressure readings

    Measured: intraoperative

  4. Heart Rate

    Intraoperative heart rate readings

    Measured: intraoperative

  5. Side effects of study drugs

    Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis).

    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 posted11 Mar 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2014
  4. Study completionAug 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385435
Sponsor's protocol ID
University of jordan
Status last verified
Mar 2015
First submitted
24 Feb 2015
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Tong Y, Ren H, Ding X, Jin S, Chen Z, Li Q. Analgesic effect and adverse events of dexmedetomidine as additive for pediatric caudal anesthesia: a meta-analysis. Paediatr Anaesth. 2014 Dec;24(12):1224-30. doi: 10.1111/pan.12519. Epub 2014 Sep 9.

    PubMed 25203847

  • She YJ, Zhang ZY, Song XR. Caudal dexmedetomidine decreases the required concentration of levobupivacaine for caudal block in pediatric patients: a randomized trial. Paediatr Anaesth. 2013 Dec;23(12):1205-12. doi: 10.1111/pan.12278. Epub 2013 Oct 12.

    PubMed 24383602

  • Bharti N, Praveen R, Bala I. A dose-response study of caudal dexmedetomidine with ropivacaine in pediatric day care patients undergoing lower abdominal and perineal surgeries: a randomized controlled trial. Paediatr Anaesth. 2014 Nov;24(11):1158-63. doi: 10.1111/pan.12478. Epub 2014 Jul 12.

    PubMed 25040840

  • Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.

    PubMed 19076110

  • El-Hennawy AM, Abd-Elwahab AM, Abd-Elmaksoud AM, El-Ozairy HS, Boulis SR. Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children. Br J Anaesth. 2009 Aug;103(2):268-74. doi: 10.1093/bja/aep159. Epub 2009 Jun 18.

    PubMed 19541679

  • Findlow D, Aldridge LM, Doyle E. Comparison of caudal block using bupivacaine and ketamine with ilioinguinal nerve block for orchidopexy in children. Anaesthesia. 1997 Nov;52(11):1110-3. doi: 10.1111/j.1365-2044.1997.204-az0346.x.

    PubMed 9404178

  • Xiang Q, Huang DY, Zhao YL, Wang GH, Liu YX, Zhong L, Luo T. Caudal dexmedetomidine combined with bupivacaine inhibit the response to hernial sac traction in children undergoing inguinal hernia repair. Br J Anaesth. 2013 Mar;110(3):420-4. doi: 10.1093/bja/aes385. Epub 2012 Nov 15.

    PubMed 23161357

  • Konakci S, Adanir T, Yilmaz G, Rezanko T. The efficacy and neurotoxicity of dexmedetomidine administered via the epidural route. Eur J Anaesthesiol. 2008 May;25(5):403-9. doi: 10.1017/S0265021507003079. Epub 2007 Dec 19.

    PubMed 18088445

  • Wu HH, Wang HT, Jin JJ, Cui GB, Zhou KC, Chen Y, Chen GZ, Dong YL, Wang W. Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014 Mar 26;9(3):e93114. doi: 10.1371/journal.pone.0093114. eCollection 2014.

    PubMed 24671181

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bupivacaine, dexmedetomidine 1μg.kg-1 and dexmedetomidine 2μg.kg-1 in people with Pain, Postoperative, 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 4 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 11 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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). The study lists 3 primary outcomes in all. 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 NCT02385435, which also lists 9 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 11 Mar 2015.

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