Postoperative PainPhase 2/3NCT02495220
Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery
A Phase 2/3 study testing SB dexmedetomidine bupivacaine block and intravenous dexmedetomidine in people with Postoperative Pain and Postoperative Vomiting, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Postoperative Pain, Postoperative Vomiting
- What is being tested?
- SB dexmedetomidine bupivacaine block and intravenous dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Nov 2017
- 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 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status grade I and II infants (1-12month).
- undergoing elective cataract surgery in one eye under general anesthesia.
Who cannot join
- infection of the orbit,
- increased intraocular pressure(IOP),
- history of allergy to local anesthetics,
- history of previous eye surgery,
- cardiovascular or clotting disorders,
- full stomach,inner ear disorders or other conditions predisposing to vomiting
- airway abnormalities
- compromised sclera.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Univeristy Hospital
Asyut, 71515
jehan A Sayed, MD, +2 01006253939, jehan.alloul@yahoo.com
MD
About this study
Official title: Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery
The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.
Read the detailed description
In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.
- Conditions
- Postoperative Pain, Postoperative Vomiting
- Being tested
- SB dexmedetomidine bupivacaine block, intravenous dexmedetomidine
- Keywords
- dexmedetomidine, subtenon anesthesia, postoperative pain, pov
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB dexmedetomidine bupivacaine blockDrug
SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
intravenous dexmedetomidineDrug
received 1µ/kg IV dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| subtenon block Group (SB) | Experimental | received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture Receives: Drug: SB dexmedetomidine bupivacaine block |
| intravenous dexmedetomidine Group(IV) | Experimental | received 1µ/kg IV dexmedetomidine after induction of anesthesia Receives: Drug: intravenous dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics
by analysis for number of infants withCRIES pain scale score >3
Measured: 4 hours postoperatively
postoperative CRIES pain scale score
(0-2 for each parameter)
Measured: 4 hours postoperatively
Secondary outcomes (2)
vomiting scale score
a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more
Measured: 4 hours postoperative
Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).
by analysis
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jehan ahmed sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495220
- Sponsor's protocol ID
- IRB00008711068
- Status last verified
- Jan 2017
- First submitted
- 3 Jul 2015
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery
- ClinicalTrials.gov ID
- NCT02495220
- Acronym / sponsor ID
- IRB00008711068
- Conditions
- Postoperative Pain, Postoperative Vomiting
- Keywords
- dexmedetomidine, subtenon anesthesia, postoperative pain, pov
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.
Detailed description
In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subtenon block Group (SB) | Experimental | Drug: SB dexmedetomidine bupivacaine blockreceived SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture |
| intravenous dexmedetomidine Group(IV) | Experimental | Drug: intravenous dexmedetomidinereceived 1µ/kg IV dexmedetomidine after induction of anesthesia |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status grade I and II infants (1-12month).
- undergoing elective cataract surgery in one eye under general anesthesia.
Key exclusion criteria (8 listed)
- infection of the orbit,
- increased intraocular pressure(IOP),
- history of allergy to local anesthetics,
- history of previous eye surgery,
- cardiovascular or clotting disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB dexmedetomidine bupivacaine blockSB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture | Drug | subtenon block Group (SB) |
| intravenous dexmedetomidinereceived 1µ/kg IV dexmedetomidine | Drug | intravenous dexmedetomidine Group(IV) |
Primary outcome
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics
Time frame: 4 hours postoperatively
by analysis for number of infants withCRIES pain scale score >3
postoperative CRIES pain scale score
Time frame: 4 hours postoperatively
(0-2 for each parameter)
2 secondary outcomes
vomiting scale score
Time frame: 4 hours postoperative
Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).
Time frame: intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SB dexmedetomidine bupivacaine block and intravenous dexmedetomidine in people with Postoperative Pain and Postoperative Vomiting, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jan 2017. 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 Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jehan A sayed, MD (+2 01006253939, jehan.alloul@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics (time frame: 4 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2017.