Dental AnxietyPhase 2NCT03827408

Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

A Phase 2 study testing Midazolam group (MDZ), Dexmedetomidine group (DEX) and Combination of Midazolam and Dexmedetomidine (MDZ/DEX) in people with Dental Anxiety, run by Nourhan M.Aly at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment. Read more about this study

Who is it for?: Ages 4 to 6 years
Conditions the study is for: Dental Anxiety
What is being tested?: Midazolam group (MDZ), Dexmedetomidine group (DEX) and Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteEgypt
Study dates: 27 Nov 2017to 22 Dec 2019
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 4 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age range 4-6 years
Frankl scale score 2.
ASA I or II physical status.
Dental intervention under local anesthesia not requiring more than 30 minutes.
No previous dental experience.
Parent/guardian"s written consent.

Who cannot join

Dental treatment indicated under general anesthesia.
Presence of facial deformities.
History of neurological or cognitive alterations.
Mouth breathers.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, 21512

Other trials in Egypt

About this study

Official title: Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Read the detailed description

Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.

Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Conditions: Dental Anxiety
Being tested: Midazolam group (MDZ), Dexmedetomidine group (DEX), Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Keywords: Nebulized Dexmedetomidine, Nebulized Midazolam, Moderate sedation, Dental procedural sedation, Pediatric dentistry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Midazolam group (MDZ)Drug
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
Dexmedetomidine group (DEX)Drug
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)Drug
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(

Study groups in NCT03827408
Study group	Role	What they receive
Midazolam group (MDZ)	Active comparator	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam. Receives: Drug: Midazolam group (MDZ)
Dexmedetomidine group (DEX)	Experimental	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine. Receives: Drug: Dexmedetomidine group (DEX)
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)	Experimental	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively. Receives: Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

What is being measured

The primary outcome is the main question the study is designed to answer.

Facemask acceptance during drug delivery
It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
Measured: during the sedation procedure
Effect of sedation on children's future behavior
Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
Measured: after one week in the follow-up session
The 'ease of treatment completion' sing separate five-point scales.
This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
Measured: immediately after completion of the dental treatment procedures.
Post-operative effects of the sedation
This will be assessed according to Modified Vernon et al.
Measured: immediately after completion of the dental treatment procedures.
Analgo-sedative effect of each drug
Onset of Sedation from drug administration until the onset of satisfactory sedation
Measured: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
Analgo-sedative effect of each drug
Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20
Measured: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Analgo-sedative effect of each drug
The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: during local anesthesia injection to start the operative procedure
Analgo-sedative effect of each drug
The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
Measured: during the sedation procedure (from its onset till meeting discharge criteria)
Analgo-sedative effect of each drug.
Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
Measured: during the sedation procedure (from its onset till meeting discharge criteria)
Amnesic effect of sedative agents.
Anterograde amnesia: will be assessed according to a modification of Bulach et al.
Measured: immediately after completion of the dental treatment procedures.
Hemodynamic response of sedative agents.
Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.
Measured: during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Vital sign: Heart rate will be counted
Measured: during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Vital sign: Oxygen saturation will be monitored using an oximeter
Measured: during the sedation procedure (from its onset till meeting discharge criteria)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 201722 Dec 2019

First posted1 Feb 2019
Study start27 Nov 2017
Primary completion29 Aug 2019
Study completion22 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Dental AnxietyStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03827408
Sponsor's protocol ID: IORG0008839
Status last verified: Jan 2020
First submitted: 22 Jan 2019
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
PubMed 25822924
Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.
PubMed 28399933
Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.
PubMed 28206886
Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.
PubMed 22144928
Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.
PubMed 25095322
Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.
PubMed 25065424
Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.
PubMed 26936022
Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.
PubMed 26989448
Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.
PubMed 27145560
Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
PubMed 15567810
Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.
PubMed 18688551
Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.
PubMed 5939538
Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
PubMed 2286697
Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
PubMed 22950484
Canpolat DG, Yildirim MD, Aksu R, Kutuk N, Alkan A, Cantekin K. Intravenous ketamine, propofol and propofol-ketamine combination used for pediatric dental sedation: A randomized clinical study. Pak J Med Sci. 2016 May-Jun;32(3):682-7. doi: 10.12669/pjms.323.9834.
PubMed 27375714

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dental Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03827408
Acronym / sponsor ID: IORG0008839
Conditions: Dental Anxiety
Keywords: Nebulized Dexmedetomidine, Nebulized Midazolam, Moderate sedation, Dental procedural sedation, Pediatric dentistry
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Nourhan M.AlyUniversity, hospital or other
Collaborators: Alexandria University
Study start: 27 Nov 2017 (actual)
Primary completion: 29 Aug 2019 (actual)
Study completion: 22 Dec 2019 (actual)
First posted: 1 Feb 2019 (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 aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Arm	Type	Receives
Midazolam group (MDZ)	Active comparator	Drug: Midazolam group (MDZ)Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
Dexmedetomidine group (DEX)	Experimental	Drug: Dexmedetomidine group (DEX)Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)	Experimental	Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Age range 4-6 years
Frankl scale score 2.
ASA I or II physical status.
Dental intervention under local anesthesia not requiring more than 30 minutes.
No previous dental experience.

Key exclusion criteria (4 listed)

Dental treatment indicated under general anesthesia.
Presence of facial deformities.
History of neurological or cognitive alterations.
Mouth breathers.

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
Midazolam group (MDZ)IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland	Drug	Midazolam group (MDZ)
Dexmedetomidine group (DEX)IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.	Drug	Dexmedetomidine group (DEX)
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(	Drug	Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

Primary outcome

Facemask acceptance during drug delivery
Time frame: during the sedation procedure
It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
Effect of sedation on children's future behavior
Time frame: after one week in the follow-up session
Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
The 'ease of treatment completion' sing separate five-point scales.
Time frame: immediately after completion of the dental treatment procedures.
This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
Post-operative effects of the sedation
Time frame: immediately after completion of the dental treatment procedures.
This will be assessed according to Modified Vernon et al.
Analgo-sedative effect of each drug
Time frame: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
Onset of Sedation from drug administration until the onset of satisfactory sedation
Analgo-sedative effect of each drug
Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20
Analgo-sedative effect of each drug
Time frame: during local anesthesia injection to start the operative procedure
The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Analgo-sedative effect of each drug
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
Analgo-sedative effect of each drug.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
Amnesic effect of sedative agents.
Time frame: immediately after completion of the dental treatment procedures.
Anterograde amnesia: will be assessed according to a modification of Bulach et al.
Hemodynamic response of sedative agents.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.
Hemodynamic response of sedative agents.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Heart rate will be counted
Hemodynamic response of sedative agents.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Oxygen saturation will be monitored using an oximeter

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 22 Jan 2020.
Background: PubMed 25822924Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
Background: PubMed 28399933Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.
Background: PubMed 28206886Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.
Background: PubMed 22144928Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.
Background: PubMed 25095322Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.
Background: PubMed 25065424Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.
Background: PubMed 26936022Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.
Background: PubMed 26989448Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.
Background: PubMed 27145560Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.
Background: PubMed 15567810Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
Background: PubMed 18688551Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.
Background: PubMed 5939538Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.
American Society of Anesthesiologists. ASA Physical Status Classification System.Link provided by the sponsor.

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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.

Amira A El-Khatib, MSc principal investigator

Alexandria University

Nadia A Wahba, PhD study director

Alexandria University

Karin ML Dowidar, PhD study director

Alexandria University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 4 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 22 Jan 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 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?

Facemask acceptance during drug delivery (time frame: during the sedation procedure). The study lists 13 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 NCT03827408, which also lists 15 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 22 Jan 2020.