Cleft PalatePhase 2NCT03412474
Suprazygomatic Block in Cleft Palate Surgery in Children
A Phase 2 study testing Bupivacaine, Dexmedetomidine and paracetamol in people with Cleft Palate, run by Assiut University at 1 site in Egypt.
Trial summary
Cleft palate (CP) is a common congenital malformation, with an incidence ranging from 0.1 to 1.1 per 1000 births depending on the population group (liau et al, 2010). Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract… Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Bupivacaine, Dexmedetomidine and paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2018to 31 Aug 2018
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 1 and 5 years
- Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
- Gender: both
Who cannot join
- Parent refusal
- History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders
- Skin lesions or wounds at the puncture site of the proposed block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Analgesic Effects of Bilateral Suprazygomatic Maxillary Nerve Block Using Bupivacaine and Dexmedetomidine in Children Undergoing Cleft Palate Repair Under General Anesthesia:Randomized Controlled Trial
Cleft palate (CP) is a common congenital malformation, with an incidence ranging from 0.1 to 1.1 per 1000 births depending on the population group (liau et al, 2010). Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections (Takemura et al., 2002).
CP repair is painful, necessitating high doses of intravenous (I.V.) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 48h postoperatively (Roulleau et al, 2003).
Read more
Maxillary nerve block using the suprazygomatic approach is used in children since it presents a lower rate of complications (Captier et al, 2009). By this way, one can reach the nerve as it exits the skull at the foramen rotundum within the pterygopalatine fossa, before the location where its nervous branches innervate the palate (Prigge et al, 2014). This simple, reliable and almost risk-free approach can yield an effective and prolonged anesthesia with a clear decreased use of morphine agents during and after cleft lip-palate surgery in small children (Mesnil et al, 2010). The nerve block must be bilateral. The local anesthetic (LA) is directly injected in the middle part of the fossa at a distance from the foramen rotundum to avoid any trauma to the nerve or vascular injury, as soon as the tip of the needle has crossed the temporal muscle (Binet et al, 2015).
Various adjuvants to local anesthetics to increase the duration of block are described in the literature and used in the daily clinical practice. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Animal studies showed that perineural dexmedetomidine added to bupivacaine or ropivacaine prolongs the duration of sensory and motor block (Brummett et al, 2011). Other clinical studies investigated the use of dexmedetomidine in patients undergoing ulnar nerve, axillary brachial and greater palatine nerve blocks, showed faster onset time and longer duration of block (Marhofer et al, 2013/ Esmaoglu et al, 2010\& Obayah et al, 2010).
Read the detailed description
Preoperative assessment:
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, physical, systemic examination and weight of the patient. All patients will be investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will include: Complete Blood Count (CBC); Prothrombin Time and Concentration (PT\& PC); Partial Thromboplastin Time (PTT) and Bleeding Time (BT). All children will be kept nil per mouth 6-8 h for solids and 2 h for clear liquids.
Preparation of the patient:
Written consent and emergency resuscitation equipments including airway devices, pediatric advanced life support drugs for LA toxicity will be available.
Intraoperative management:
All patients in this study will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
General anesthesia will be standardized for all patients in both groups using 8 MAC sevoflurane in 100% O2 with appropriate size face mask. Intraoperative monitoring will include ECG, pulse oximetry, noninvasive blood pressure, capnography and temperature probe. After intravenous access securing, endotracheal intubation with appropriate size to the patient's age will be performed after administration of 2 mg/kg propofol.
After orotracheal intubation, assisted mechanical ventilation using Ayre's T- piece will be used to maintain end-tidal carbon dioxide at 35±5 mmHg. General anesthesia will be maintained with 2-3 MAC sevoflurane.
Intraoperatively, patients will receive an infusion of normal saline 0.9% solution 4ml/ kg / h.
Bilateral SMB will be performed before surgery in anesthetized children, after aseptic preparation of the skin. The patient will be in supine position with the head in neutral position. The puncture site will be at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal bone. A needle with 50 mm length and 25 gauge will be inserted perpendicular to the skin. It will be advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimeters and will be redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa will be 35 to 45 mm. Loss of resistance after passing through the temporalis muscle will assist in determining the puncture depth. After a negative blood aspiration test, 0.2 ml/kg of the blinded study solution will be injected on each side (Captier et al, 2009).
MAP, HR, SPO2 and end-tidal CO2 will be recorded before induction of anesthesia, before block, after the block and every 10 minutes till end of surgery. Skin incision will be made 20 minutes after SMB block. An increase in HR and MAP above 20% of baseline values with skin incision will be considered as a sign of inadequate analgesia. In this case, fentanyl 1 µg/kg will be given intravenously, and the case will be excluded from the study.
Immediate complications related to regional anesthesia will be recorded:
- Systemic toxicity related to local anesthetics (seizures, heart rhythm, or conduction disorder)
- Bleeding at puncture site
- Pupil alteration and ocular lesion
Before the end of surgery, IV paracetamol 15 mg/kg and dexamethasone 0.2 mg/kg will be administered.
After completion of the surgical procedure, extubation will be done after ensuring adequate orogastric suction and patients will be transferred to the postanesthesia care unit (PACU).
In PACU: MAP, HR, modified CHEOPS, POV and sedation score will be recorded on admission to PACU, 1, 4, 8, 12, 18, 24h postoperatively by an observer who will be unaware of the study protocol.
Postoperative pain will be measured using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (Taddio et al, 1995).
CHEOPS = SUM (points for all 6 parameters)
Interpretation:
- minimum score: 4
- maximum score: 13 Patients with modified CHEOPS > 6 will be given rescue analgesia with 15 mg/kg paracetamol intravenously. Those with modified CHEOPS of 4-5 will be given paracetamol 25-40 mg/kg as suppository. Pain scores will be recorded every 10 minutes after administration of rescue analgesia to evaluate pain relief or need for further rescue analgesia. The number of children who will need postoperative rescue analgesics and the duration of analgesia that will be taken at the time when an analgesic is required will be recorded.
Postoperative vomiting episodes will be recorded and treated with intravenous metoclopramide 0.5 mg/kg. Postoperative sedation will be assessed using sedation score described by Culebras et al, 2001 (1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unarousable).
Delayed complications of the blocks will be also investigated and recorded as hematoma, restricted mouth opening, vision, sensory or motor deficit, eating disorder, and local infection.
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 48h postoperatively through 5-point Likertscale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied).
Patients will be discharged from the hospital when they are pain free and there is no other medical reason to admit them to a surgical ward.
- Conditions
- Cleft Palate
- Being tested
- Bupivacaine, Dexmedetomidine, paracetamol
- Keywords
- suprazygomatic block, dexmedetomidine
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
The study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection. Patients will be randomly allocated into two groups of 40 patients each:
Group A: will receive 0.2 ml/kg/side of bupivacaine (0.125%).
DexmedetomidineDrug
Group B: will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine.
paracetamolDrug
paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%). Receives: Drug: Bupivacaine; Drug: paracetamol |
| Dexmedetomidine | Active comparator | Patients will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine. Receives: Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
postoperative pain assessment in children minimum score: 4, maximum score: 13 Patients with modified CHEOPS > 6 will be given rescue analgesia
Measured: 24 hours
Secondary outcomes (2)
time to first analgesia
time of intravenous paracetamol requirment postoperatively
Measured: 24 hours
5-point Likert scale
parent satisfaction score
(1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start14 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison of the analgesic effect of adding dexmedetomidine to bupivacaine with the analgesic effect of using bupivacaine alone in bilateral SMB for children undergoing CP repair under general anesthesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAGAA AHMED HERDAN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412474
- Sponsor's protocol ID
- suprazygomatic block
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Analgesic Effects of Bilateral Suprazygomatic Maxillary Nerve Block Using Bupivacaine and Dexmedetomidine in Children Undergoing Cleft Palate Repair Under General Anesthesia:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03412474
- Acronym / sponsor ID
- suprazygomatic block
- Conditions
- Cleft Palate
- Keywords
- suprazygomatic block, dexmedetomidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Jan 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.
Cleft palate (CP) is a common congenital malformation, with an incidence ranging from 0.1 to 1.1 per 1000 births depending on the population group (liau et al, 2010). Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections (Takemura et al., 2002).
CP repair is painful, necessitating high doses of intravenous (I.V.) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 48h postoperatively (Roulleau et al, 2003).
Maxillary nerve block using the suprazygomatic approach is used in children since it presents a lower rate of complications (Captier et al, 2009). By this way, one can reach the nerve as it exits the skull at the foramen rotundum within the pterygopalatine fossa, before the location where its nervous branches innervate the palate (Prigge et al, 2014). This simple, reliable and almost risk-free approach can yield an effective and prolonged anesthesia with a clear decreased use of morphine agents during and after cleft lip-palate surgery in small children (Mesnil et al, 2010). The nerve block must be bilateral. The local anesthetic (LA) is directly injected in the middle part of the fossa at a distance from the foramen rotundum to avoid any trauma to the nerve or vascular injury, as soon as the tip of the needle has crossed the temporal muscle (Binet et al, 2015).
Various adjuvants to local anesthetics to increase the duration of block are described in the literature and used in the daily clinical practice. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Animal studies showed that perineural dexmedetomidine added to bupivacaine or ropivacaine prolongs the duration of sensory and motor block (Brummett et al, 2011). Other clinical studies investigated the use of dexmedetomidine in patients undergoing ulnar nerve, axillary brachial and greater palatine nerve blocks, showed faster onset time and longer duration of block (Marhofer et al, 2013/ Esmaoglu et al, 2010\& Obayah et al, 2010).
Detailed description
Preoperative assessment:
The day prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, physical, systemic examination and weight of the patient. All patients will be investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will include: Complete Blood Count (CBC); Prothrombin Time and Concentration (PT\& PC); Partial Thromboplastin Time (PTT) and Bleeding Time (BT). All children will be kept nil per mouth 6-8 h for solids and 2 h for clear liquids.
Preparation of the patient:
Written consent and emergency resuscitation equipments including airway devices, pediatric advanced life support drugs for LA toxicity will be available.
Intraoperative management:
All patients in this study will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
General anesthesia will be standardized for all patients in both groups using 8 MAC sevoflurane in 100% O2 with appropriate size face mask. Intraoperative monitoring will include ECG, pulse oximetry, noninvasive blood pressure, capnography and temperature probe. After intravenous access securing, endotracheal intubation with appropriate size to the patient's age will be performed after administration of 2 mg/kg propofol.
After orotracheal intubation, assisted mechanical ventilation using Ayre's T- piece will be used to maintain end-tidal carbon dioxide at 35±5 mmHg. General anesthesia will be maintained with 2-3 MAC sevoflurane.
Intraoperatively, patients will receive an infusion of normal saline 0.9% solution 4ml/ kg / h.
Bilateral SMB will be performed before surgery in anesthetized children, after aseptic preparation of the skin. The patient will be in supine position with the head in neutral position. The puncture site will be at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal bone. A needle with 50 mm length and 25 gauge will be inserted perpendicular to the skin. It will be advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimeters and will be redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa will be 35 to 45 mm. Loss of resistance after passing through the temporalis muscle will assist in determining the puncture depth. After a negative blood aspiration test, 0.2 ml/kg of the blinded study solution will be injected on each side (Captier et al, 2009).
MAP, HR, SPO2 and end-tidal CO2 will be recorded before induction of anesthesia, before block, after the block and every 10 minutes till end of surgery. Skin incision will be made 20 minutes after SMB block. An increase in HR and MAP above 20% of baseline values with skin incision will be considered as a sign of inadequate analgesia. In this case, fentanyl 1 µg/kg will be given intravenously, and the case will be excluded from the study.
Immediate complications related to regional anesthesia will be recorded:
- Systemic toxicity related to local anesthetics (seizures, heart rhythm, or conduction disorder)
- Bleeding at puncture site
- Pupil alteration and ocular lesion
Before the end of surgery, IV paracetamol 15 mg/kg and dexamethasone 0.2 mg/kg will be administered.
After completion of the surgical procedure, extubation will be done after ensuring adequate orogastric suction and patients will be transferred to the postanesthesia care unit (PACU).
In PACU: MAP, HR, modified CHEOPS, POV and sedation score will be recorded on admission to PACU, 1, 4, 8, 12, 18, 24h postoperatively by an observer who will be unaware of the study protocol.
Postoperative pain will be measured using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (Taddio et al, 1995).
CHEOPS = SUM (points for all 6 parameters)
Interpretation:
- minimum score: 4
- maximum score: 13 Patients with modified CHEOPS > 6 will be given rescue analgesia with 15 mg/kg paracetamol intravenously. Those with modified CHEOPS of 4-5 will be given paracetamol 25-40 mg/kg as suppository. Pain scores will be recorded every 10 minutes after administration of rescue analgesia to evaluate pain relief or need for further rescue analgesia. The number of children who will need postoperative rescue analgesics and the duration of analgesia that will be taken at the time when an analgesic is required will be recorded.
Postoperative vomiting episodes will be recorded and treated with intravenous metoclopramide 0.5 mg/kg. Postoperative sedation will be assessed using sedation score described by Culebras et al, 2001 (1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unarousable).
Delayed complications of the blocks will be also investigated and recorded as hematoma, restricted mouth opening, vision, sensory or motor deficit, eating disorder, and local infection.
The parents will be asked to evaluate their satisfaction regarding pain control at the end of 48h postoperatively through 5-point Likertscale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied).
Patients will be discharged from the hospital when they are pain free and there is no other medical reason to admit them to a surgical ward.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison of the analgesic effect of adding dexmedetomidine to bupivacaine with the analgesic effect of using bupivacaine alone in bilateral SMB for children undergoing CP repair under general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: paracetamolPatients will receive 0.2 ml/kg/side of bupivacaine (0.125%). |
| Dexmedetomidine | Active comparator | Drug: Bupivacaine, Drug: Dexmedetomidine, Drug: paracetamolPatients will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 1 and 5 years
- Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
- Gender: both
Key exclusion criteria (6 listed)
- Parent refusal
- History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system 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 |
|---|---|---|
| BupivacaineThe study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection. Patients will be randomly allocated into two groups of 40 patients each: Group A: will receive 0.2 ml/kg/side of bupivacaine (0.125%). | Drug | Bupivacaine, Dexmedetomidine |
| DexmedetomidineGroup B: will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine. | Drug | Dexmedetomidine |
| paracetamolparacetamol | Drug | Bupivacaine, Dexmedetomidine |
Primary outcome
modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Time frame: 24 hours
postoperative pain assessment in children minimum score: 4, maximum score: 13 Patients with modified CHEOPS > 6 will be given rescue analgesia
2 secondary outcomes
time to first analgesia
Time frame: 24 hours
5-point Likert scale
Time frame: 24 hours
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 24 Sep 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine, Dexmedetomidine and paracetamol in people with Cleft Palate, 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 3 inclusion and 6 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 24 Sep 2018. 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 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?
modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (time frame: 24 hours). 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 24 Sep 2018.