Post-Dural Puncture HeadacheNCT04327726
Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache
A study testing Dexmedetomidine Nebulization and 0.9% Saline Nebulization in people with Post-Dural Puncture Headache, run by Zagazig University at 1 site in Egypt.
Trial summary
Postdural puncture headache (PDPH) is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Dexmedetomidine Nebulization and 0.9% Saline Nebulization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 28 Feb 2021
- Phase
- Interventional
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-partum females diagnosed with PDPH after elective caesarean section under spinal anesthesia and with visual analogue score (VAS) ≥ 4 and Lybecker et al. classification score ≥2.
- Age 21- 40 years old.
- ASA I and ASA II.
- Accepted mental state of the patient.
Who cannot join
- Patient refusal.
- ASA Grade III and IV.
- Emergent caesarean section.
- Inadequate temporal window.
- Hypertensive disorders of the pregnancy.
- Atrial fibrillation.
Show all 9Show fewer
- History of allergy to local anesthetics.
- History of chronic headache, migraine, convulsions, and cerebrovascular accident.
- Contraindication to spinal anesthesia: coagulopathy, infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nebulized Dexmedetomidine for Treatment of Post-Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: Randomized Controlled Study
Postdural puncture headache (PDPH) is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia.
Dexmedetomidine is a highly selective, centrally acting α2-adrenergic agonist with analgesic and anxiolytic effects. Moreover, it decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. It has been used via the intranasal and inhalational routes for many purposes including premedication, sedation and postoperative analgesia. Because of its desirable properties, we hypothesized that dexmedetomidine nebulization could be effective in the treatment of patients suffering from PDPH after caesarean section.
Read the detailed description
Post-Dural puncture headache (PDPH) is a well-known common devastating complication of subarachnoid block. Despite the decreasing incidences of PDPH over the last years due to the advancement in the design and smaller size of spinal needles, PDPH remains to be a common complication in post-partum patients. Female gender, typically pregnant females, young age, low body mass index, dilutional anemia, and the preference of neuraxial anesthesia for Cesarean Section renders obstetric patients to be more exposed to PDPH. Consequently, treating this complication is of paramount importance in obstetric anesthesia.
The cause of PDPH is not entirely known but there is a considerable evidence support the explanation of the low cerebrospinal fluid (CSF) pressure resulting from continuous CSF leak through the tear in meninges that exceeds the CSF production rate as a main cause of PDPH. As little as 10% CSF volume loss could induce PDPH from the traction on the pain sensitive intracranial structures in the upright position combined with reflex vasodilatation. Several treatment options have been proposed which are usually consisting of bed rest in supine position, fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.
Dexmedetomidine (Dex) is a highly selective centrally acting α2-adrenoreceptor agonist that produces cooperative sedation, anxiolysis, and analgesia with minimal respiratory depression. Moreover it was found to attenuate the stress and inflammatory response to anesthetic and surgical procedures. Stimulation of α2-receptors in substantia gelatinosa of the dorsal horn leads to suppression of nociceptive neurons firing and inhibition of substance-P release also, its stimulation in the locus coeruleus area which is known to be a significant nociceptive transmission modulator terminates pain signals transmission resulting in analgesia. Additionally, an existing literature supports that Dex decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. Thus, the use of Dex might be a useful adjunct in certain situations that require cerebral vasoconstriction together with analgesia such as PDPH. The present study will be undertaken to test this hypothesis.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Dexmedetomidine Nebulization, 0.9% Saline Nebulization
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine NebulizationDrug
ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment
0.9% Saline NebulizationOther
nebulization of 4mL 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | received ultrasonic nebulization of 4mL 0.9% saline twice daily for 3 days Receives: Other: 0.9% Saline Nebulization |
| Dexmedetomidine group | Active comparator | received ultrasonic nebulization of 1 µg/kg dexmedetomidine diluted in 4mL 0.9% saline twice daily for 3 days. The intervention will be continued until achieving a VAS score ≤3 and Lybecker et al. classification score <2 and or for a maximum of 72 hours. Patients in this group who achieved the target scores before 72 hours will be given 4ml of saline 0.9% nebulization to maintain blinding. Receives: Drug: Dexmedetomidine Nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score (VAS)
using the 10-cm visual analogue score (VAS) where score 0 is no headache and 10 is the worst imaginable headache with 1-3 classified as mild, 4-6 moderate, and 7-10 severe our aim to get VAS </= 3 at 24 hour from starting treatment
Measured: 24 hour
Lybecker headache classification score
our aim to get Lybecker score < 2 at 24hour following treatment Lybecker et al. classification of PDPH score 1: Mild PDPH where daily activities slightly restricted. Patient is not bedridden.
No associated symptoms*. Score 2:Moderate: Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms.
Score 3:Severe Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms Associated symptoms include: Nausea, vomiting, vertigo, dizziness, tinnitus Photophobia, diplopia, and neck stiffness.
Measured: 24 hour
Secondary outcomes (2)
the effects of nebulized dexmedetomidine on cerebral blood flow by using Trans-Cranial Doppler (TCD)
TCD measurements (mean flow velocity, pulsatility index) will be performed at 0, 24, 48, 72hours
Measured: 72 hours
adverse effects related to nebulized Dexmedetomidine
occurrence of any adverse effects (Hypotension, bradycardia, sedation) related to nebulized Dexmedetomidine
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 May 2020
- Primary completion30 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Sherif M Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig UniversityShereen E Abd Ellatif, MD, Study director, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327726
- Sponsor's protocol ID
- 6075-26-4-2020
- Status last verified
- May 2021
- First submitted
- 28 Mar 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in the publication
Publications
Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
PubMed 25146108Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29.
PubMed 26222393FitzGerald S, Salman M. Postdural puncture headache in obstetric patients. Br J Gen Pract. 2019 Apr;69(681):207-208. doi: 10.3399/bjgp19X702125. No abstract available.
PubMed 30923161Shah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 2002; 46(5):373-377.
Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.
PubMed 14570796Amorim JA, Gomes de Barros MV, Valenca MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012 Sep;32(12):916-23. doi: 10.1177/0333102412453951. Epub 2012 Jul 27.
PubMed 22843225Uyar Turkyilmaz E, Eryilmaz NC, Guzey NA, Moraloglu O. [Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations]. Rev Bras Anestesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjan.2015.12.001. Epub 2016 Jul 18. Portuguese.
PubMed 27445257Tsaousi GG, Bilotta F. Is dexmedetomidine a favorable agent for cerebral hemodynamics? Indian J Crit Care Med. 2016 Jan;20(1):1-2. doi: 10.4103/0972-5229.173675. No abstract available.
PubMed 26955209Tang C, Huang X, Kang F, Chai X, Wang S, Yin G, Wang H, Li J. Intranasal Dexmedetomidine on Stress Hormones, Inflammatory Markers, and Postoperative Analgesia after Functional Endoscopic Sinus Surgery. Mediators Inflamm. 2015;2015:939431. doi: 10.1155/2015/939431. Epub 2015 Jun 25.
PubMed 26199465Jaakola ML, Salonen M, Lehtinen R, Scheinin H. The analgesic action of dexmedetomidine--a novel alpha 2-adrenoceptor agonist--in healthy volunteers. Pain. 1991 Sep;46(3):281-285. doi: 10.1016/0304-3959(91)90111-A.
PubMed 1684653Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
PubMed 16369581Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13.
PubMed 17299013Drummond JC, Dao AV, Roth DM, Cheng CR, Atwater BI, Minokadeh A, Pasco LC, Patel PM. Effect of dexmedetomidine on cerebral blood flow velocity, cerebral metabolic rate, and carbon dioxide response in normal humans. Anesthesiology. 2008 Feb;108(2):225-32. doi: 10.1097/01.anes.0000299576.00302.4c.
PubMed 18212567Kumar A, Kumar A, Sinha C, Anant M, Singh JK. Dexmedetomidine nebulization: an answer to post-dural puncture headache? Int J Obstet Anesth. 2019 Nov;40:155-156. doi: 10.1016/j.ijoa.2019.06.004. Epub 2019 Jun 19. No abstract available.
PubMed 31345663Lybecker H, Djernes M, Schmidt JF. Postdural puncture headache (PDPH): onset, duration, severity, and associated symptoms. An analysis of 75 consecutive patients with PDPH. Acta Anaesthesiol Scand. 1995 Jul;39(5):605-12. doi: 10.1111/j.1399-6576.1995.tb04135.x.
PubMed 7572008
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nebulized Dexmedetomidine for Treatment of Post-Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04327726
- Acronym / sponsor ID
- 6075-26-4-2020
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 Mar 2020 (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.
Postdural puncture headache (PDPH) is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia.
Dexmedetomidine is a highly selective, centrally acting α2-adrenergic agonist with analgesic and anxiolytic effects. Moreover, it decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. It has been used via the intranasal and inhalational routes for many purposes including premedication, sedation and postoperative analgesia. Because of its desirable properties, we hypothesized that dexmedetomidine nebulization could be effective in the treatment of patients suffering from PDPH after caesarean section.
Detailed description
Post-Dural puncture headache (PDPH) is a well-known common devastating complication of subarachnoid block. Despite the decreasing incidences of PDPH over the last years due to the advancement in the design and smaller size of spinal needles, PDPH remains to be a common complication in post-partum patients. Female gender, typically pregnant females, young age, low body mass index, dilutional anemia, and the preference of neuraxial anesthesia for Cesarean Section renders obstetric patients to be more exposed to PDPH. Consequently, treating this complication is of paramount importance in obstetric anesthesia.
The cause of PDPH is not entirely known but there is a considerable evidence support the explanation of the low cerebrospinal fluid (CSF) pressure resulting from continuous CSF leak through the tear in meninges that exceeds the CSF production rate as a main cause of PDPH. As little as 10% CSF volume loss could induce PDPH from the traction on the pain sensitive intracranial structures in the upright position combined with reflex vasodilatation. Several treatment options have been proposed which are usually consisting of bed rest in supine position, fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.
Dexmedetomidine (Dex) is a highly selective centrally acting α2-adrenoreceptor agonist that produces cooperative sedation, anxiolysis, and analgesia with minimal respiratory depression. Moreover it was found to attenuate the stress and inflammatory response to anesthetic and surgical procedures. Stimulation of α2-receptors in substantia gelatinosa of the dorsal horn leads to suppression of nociceptive neurons firing and inhibition of substance-P release also, its stimulation in the locus coeruleus area which is known to be a significant nociceptive transmission modulator terminates pain signals transmission resulting in analgesia. Additionally, an existing literature supports that Dex decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. Thus, the use of Dex might be a useful adjunct in certain situations that require cerebral vasoconstriction together with analgesia such as PDPH. The present study will be undertaken to test this hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: 0.9% Saline Nebulizationreceived ultrasonic nebulization of 4mL 0.9% saline twice daily for 3 days |
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidine Nebulizationreceived ultrasonic nebulization of 1 µg/kg dexmedetomidine diluted in 4mL 0.9% saline twice daily for 3 days. The intervention will be continued until achieving a VAS score ≤3 and Lybecker et al. classification score <2 and or for a maximum of 72 hours. Patients in this group who achieved the target scores before 72 hours will be given 4ml of saline 0.9% nebulization to maintain blinding. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Post-partum females diagnosed with PDPH after elective caesarean section under spinal anesthesia and with visual analogue score (VAS) ≥ 4 and Lybecker et al. classification score ≥2.
- Age 21- 40 years old.
- ASA I and ASA II.
- Accepted mental state of the patient.
Key exclusion criteria (9 listed)
- Patient refusal.
- ASA Grade III and IV.
- Emergent caesarean section.
- Inadequate temporal window.
- Hypertensive disorders of the pregnancy.
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 Nebulizationultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment | Drug | Dexmedetomidine group |
| 0.9% Saline Nebulizationnebulization of 4mL 0.9% saline | Other | Control group |
Primary outcome
visual analogue score (VAS)
Time frame: 24 hour
using the 10-cm visual analogue score (VAS) where score 0 is no headache and 10 is the worst imaginable headache with 1-3 classified as mild, 4-6 moderate, and 7-10 severe our aim to get VAS </= 3 at 24 hour from starting treatment
Lybecker headache classification score
Time frame: 24 hour
our aim to get Lybecker score < 2 at 24hour following treatment Lybecker et al. classification of PDPH score 1: Mild PDPH where daily activities slightly restricted. Patient is not bedridden. No associated symptoms*. Score 2:Moderate: Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms. Score 3:Severe Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms Associated symptoms include: Nausea, vomiting, vertigo, dizziness, tinnitus Photophobia, diplopia, and neck stiffness.
2 secondary outcomes
the effects of nebulized dexmedetomidine on cerebral blood flow by using Trans-Cranial Doppler (TCD)
Time frame: 72 hours
adverse effects related to nebulized Dexmedetomidine
Time frame: 72 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 12 May 2021.
- Background: PubMed 25146108Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
- Background: PubMed 26222393Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29.
- Background: PubMed 30923161FitzGerald S, Salman M. Postdural puncture headache in obstetric patients. Br J Gen Pract. 2019 Apr;69(681):207-208. doi: 10.3399/bjgp19X702125. No abstract available.
- BackgroundShah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 2002; 46(5):373-377.
- Background: PubMed 14570796Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.
- Background: PubMed 22843225Amorim JA, Gomes de Barros MV, Valenca MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012 Sep;32(12):916-23. doi: 10.1177/0333102412453951. Epub 2012 Jul 27.
- Background: PubMed 27445257Uyar Turkyilmaz E, Eryilmaz NC, Guzey NA, Moraloglu O. [Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations]. Rev Bras Anestesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjan.2015.12.001. Epub 2016 Jul 18. Portuguese.
- Background: PubMed 26955209Tsaousi GG, Bilotta F. Is dexmedetomidine a favorable agent for cerebral hemodynamics? Indian J Crit Care Med. 2016 Jan;20(1):1-2. doi: 10.4103/0972-5229.173675. No abstract available.
- Background: PubMed 26199465Tang C, Huang X, Kang F, Chai X, Wang S, Yin G, Wang H, Li J. Intranasal Dexmedetomidine on Stress Hormones, Inflammatory Markers, and Postoperative Analgesia after Functional Endoscopic Sinus Surgery. Mediators Inflamm. 2015;2015:939431. doi: 10.1155/2015/939431. Epub 2015 Jun 25.
- Background: PubMed 1684653Jaakola ML, Salonen M, Lehtinen R, Scheinin H. The analgesic action of dexmedetomidine--a novel alpha 2-adrenoceptor agonist--in healthy volunteers. Pain. 1991 Sep;46(3):281-285. doi: 10.1016/0304-3959(91)90111-A.
- Background: PubMed 16369581Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
- Background: PubMed 17299013Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results in the publication
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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.
Sherif M Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
Shereen E Abd Ellatif, MD study director
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Nebulization and 0.9% Saline Nebulization in people with Post-Dural Puncture Headache, run by Zagazig 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 4 inclusion and 9 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 12 May 2021. 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. 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.
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?
visual analogue score (VAS) (time frame: 24 hour). 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?
On the ClinicalTrials.gov record for NCT04327726, which also lists 17 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 12 May 2021.