Cleft PalatePhase 3NCT04928391
A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation
A Phase 3 study testing Dexmedetomidine and 0.9% saline in people with Cleft Palate, run by Assiut University at 2 sites in Egypt.
Trial summary
The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Dexmedetomidine and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jun 2021to 20 Mar 2026
- Phase
- Phase 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
- Elective cleft palate repair ± cleft lip surgery under general anesthesia.
Who cannot join
- Ventriculo-peritoneal shunt
- Suspected meningitis
- Congenital hydrocephalus
- Clinical signs of suspected increased intracranial pressure
- On treatment for seizures or metabolic diseases
- Children with developmental delay
- Hypersensitivity to dexmedetomidine or nalbuphine
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Omar Soliman
Asyut, Assuit, Assuit universi
Assiut university hospital
Asyut
About this study
Official title: Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Normal Saline in Children With Cleft Palate Repair
The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.
Read the detailed description
A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or same volume of saline placebo (Group C).
- Conditions
- Cleft Palate
- Being tested
- Dexmedetomidine, 0.9% saline
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery
0.9% salineOther
Also called Normal saline
Same volume of saline placebo IV at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | Dexmedetomidine IV at the end of surgery Receives: Drug: Dexmedetomidine |
| Group C | Placebo comparator | Same volume of saline placebo IV at the end of surgery Receives: Other: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Pediatric Anesthesia Emergence Delirium (PAED) score
Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
Measured: 1 hour postoperative
Secondary outcomes (1)
FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.
The FLACC is a behavioural pain assessment scale for use for non-verbal or pre-verbal patients unable to self-report their level of pain. Rate your child in each of the five measurement categories, add together, and document total pain score (0 - 10), score 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.
Measured: 1 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start20 Jun 2021
- Primary completion5 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928391
- Sponsor's protocol ID
- 17300616
- Status last verified
- May 2026
- First submitted
- 10 Jun 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milic M, Goranovic T, Knezevic P. Complications of sevoflurane-fentanyl versus midazolam-fentanyl anesthesia in pediatric cleft lip and palate surgery: a randomized comparison study. Int J Oral Maxillofac Surg. 2010 Jan;39(1):5-9. doi: 10.1016/j.ijom.2009.09.007. Epub 2009 Oct 24.
PubMed 19854614
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Normal Saline in Children With Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT04928391
- Acronym / sponsor ID
- 17300616
- Conditions
- Cleft Palate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 16 Jun 2021 (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.
The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.
Detailed description
A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or same volume of saline placebo (Group C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: DexmedetomidineDexmedetomidine IV at the end of surgery |
| Group C | Placebo comparator | Other: 0.9% salineSame volume of saline placebo IV at the end of surgery |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
- Elective cleft palate repair ± cleft lip surgery under general anesthesia.
Key exclusion criteria (7 listed)
- Ventriculo-peritoneal shunt
- Suspected meningitis
- Congenital hydrocephalus
- Clinical signs of suspected increased intracranial pressure
- On treatment for seizures or metabolic diseases
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexA single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery | Drug | Group D |
| 0.9% salineAlso: Normal salineSame volume of saline placebo IV at the end of surgery | Other | Group C |
Primary outcome
the Pediatric Anesthesia Emergence Delirium (PAED) score
Time frame: 1 hour postoperative
Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
1 secondary outcome
FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.
Time frame: 1 hour postoperative
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 May 2026.
- Results publication: PubMed 19854614Milic M, Goranovic T, Knezevic P. Complications of sevoflurane-fentanyl versus midazolam-fentanyl anesthesia in pediatric cleft lip and palate surgery: a randomized comparison study. Int J Oral Maxillofac Surg. 2010 Jan;39(1):5-9. doi: 10.1016/j.ijom.2009.09.007. Epub 2009 Oct 24.
- Individual participant dataSharing planned: Undecided
Related trials for Cleft Palate
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Furlow With Buccinator and Fistula Formation
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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.
Omar Soliman study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and 0.9% saline in people with Cleft Palate, run by Assiut University at 2 sites 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 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 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?
the Pediatric Anesthesia Emergence Delirium (PAED) score (time frame: 1 hour postoperative). 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 NCT04928391, 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 7 May 2026.