Cleft LipPhase 4NCT03480607
Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair
A Phase 4 study testing Dexmedetomidine group and Dexamethasone group in people with Cleft Lip, run by Mansoura University at 1 site in Egypt.
Trial summary
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Cleft Lip
- What is being tested?
- Dexmedetomidine group and Dexamethasone group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 10 May 2018
- Phase
- Phase 4
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologist (ASA) physical status I or II
Who cannot join
- known allergy to any of drugs used
- coagulopathy
- any wound or infection related to puncture site
- major illness
- failure to gain consent of parents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
Read the detailed description
Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.
Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
- Conditions
- Cleft Lip
- Being tested
- Dexmedetomidine group, Dexamethasone group
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine groupDrug
0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine
Dexamethasone groupDrug
0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block Receives: Drug: Dexmedetomidine group |
| Dexamethasone group | Active comparator | Dexamethasone in conjunction with bupivacaine f Receives: Drug: Dexamethasone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative FLACC scale
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
Measured: for 24 hours after surgery
Postoperative sedation score
The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2,
Measured: for 4 hours after surgery
Secondary outcomes (5)
Heart rate
(beat/min)
Measured: For 4 hours after induction
Systolic blood pressure
(mmHg)
Measured: For 4 hours after induction
Postoperative nausea
As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks.
Measured: for 24 hours after surgery
Haematoma formation after surgery
That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation
Measured: for 24 hours after surgery
Postoperative vomiting
Measured: for 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Aug 2017
- Primary completion30 Apr 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas Abd el Motlb, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480607
- Sponsor's protocol ID
- R/17.05.85
- Status last verified
- Sep 2020
- First submitted
- 7 Mar 2018
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
- ClinicalTrials.gov ID
- NCT03480607
- Acronym / sponsor ID
- R/17.05.85
- Conditions
- Cleft Lip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
Detailed description
Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.
Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidine groupDexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block |
| Dexamethasone group | Active comparator | Drug: Dexamethasone groupDexamethasone in conjunction with bupivacaine f |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American society of anesthesiologist (ASA) physical status I or II
Key exclusion criteria (5 listed)
- known allergy to any of drugs used
- coagulopathy
- any wound or infection related to puncture site
- major illness
- failure to gain consent of parents.
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 |
|---|---|---|
| Dexmedetomidine group0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine | Drug | Dexmedetomidine group |
| Dexamethasone group0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone | Drug | Dexamethasone group |
Primary outcome
Postoperative FLACC scale
Time frame: for 24 hours after surgery
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
Postoperative sedation score
Time frame: for 4 hours after surgery
The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2,
5 secondary outcomes
Heart rate
Time frame: For 4 hours after induction
Systolic blood pressure
Time frame: For 4 hours after induction
Postoperative nausea
Time frame: for 24 hours after surgery
Haematoma formation after surgery
Time frame: for 24 hours after surgery
Postoperative vomiting
Time frame: for 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Enas Abd el Motlb, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine group and Dexamethasone group in people with Cleft Lip, run by Mansoura 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 1 inclusion and 5 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 7 Sep 2020. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postoperative FLACC scale (time frame: for 24 hours after surgery). 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 7 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.