Burning NosePhase 2/3INMNCT03725995
Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children
A Phase 2/3 study testing Midazolam and Lidocaine-Midazolam in people with Burning Nose, run by Latakia University at 1 site in Syria.
Trial summary
Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration. Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Nose
- What is being tested?
- Midazolam and Lidocaine-Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jun 2017to 10 Oct 2018
- Phase
- Phase 2/3
- 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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- uncooperative children scored 1 or 2 on Frankle Scale.
- had no medical history of neurological or cognitive alterations.
- No facial deformities.
- ASA Classification I.
- requiring dental treatment under local anesthesia.
Who cannot join
- known allergy to midazolam or any other benzodiazepines.
- upper respiratory tract infection with nasal discharge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.
Read the detailed description
Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:
A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.
C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.
- Conditions
- Burning Nose
- Being tested
- Midazolam, Lidocaine-Midazolam, Placebo
- Keywords
- midazolam, Lidocaine, Intranasal, Burning, Children
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called A
Patients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
Lidocaine-MidazolamDrug
Also called B
Patients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
PlaceboDrug
Also called C
Patients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
| Study group | Role | What they receive |
|---|---|---|
| A (Midazolam) | Active comparator | 21 children received 0.5 mg/kg intranasal medication (midazolam), with a maximum dose of 10 mg, via a spray of 0.2 ml per puff, administering the drug was alternated between the two nostrils of the child. Receives: Drug: Midazolam |
| B (Lidocaine-Midazolam) | Experimental | 21 children received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg intranasal medication (midazolam),administering the drug was alternated between the two nostrils of the child, with a maximum dose of 10 mg via a spray of 0.2 ml per puff. Receives: Drug: Lidocaine-Midazolam |
| C (Placebo) | Placebo comparator | 21 children received intranasal medication (saline 9% as placebo), 0.5 mg/kg, with a maximum dose of 10 mg via a spray of 0.2 ml per puff,administering the drug was alternated between the two nostrils of the child. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
The use of intranasal midazolam is associated with a burning sensation of the nasal mucosa, the pain was assessed using a self report pain scale Wong Baker Faces Scale, the degree of pain is determined by choosing a score of (0-2-4-6-8-10) (minimum score 0, means no pain, maximum score 10, means the drug hurts worst, higher scores are worse) the scores were reported by children received intranasal midazolam alone, intranasal midazolam preceded by intranasal lidocaine or intranasal saline (placebo).
Measured: one to five minutes following the administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Jun 2017
- Primary completion1 Jan 2018
- Study completion10 Oct 2018
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 Burning NoseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- blinded, randomized placebo-controlled trial, comparing three groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabih Raslan, Latakia University
- Investigators
- Nabih Raslan, Dr., Study chair, Latakia UniversityWalaa Khalil, Dr., Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725995
- Sponsor's protocol ID
- Tishreen U- PediatricDentistry
- Acronym
- INM
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: up to date, there is no decision about IPD sharing.
Publications
Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
PubMed 27739142
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03725995
- Acronym / sponsor ID
- INM / Tishreen U- PediatricDentistry
- Conditions
- Burning Nose
- Keywords
- midazolam, Lidocaine, Intranasal, Burning, Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 31 Oct 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.
Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.
Detailed description
Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:
A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.
C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- blinded, randomized placebo-controlled trial, comparing three groups.
| Arm | Type | Receives |
|---|---|---|
| A (Midazolam) | Active comparator | Drug: Midazolam21 children received 0.5 mg/kg intranasal medication (midazolam), with a maximum dose of 10 mg, via a spray of 0.2 ml per puff, administering the drug was alternated between the two nostrils of the child. |
| B (Lidocaine-Midazolam) | Experimental | Drug: Lidocaine-Midazolam21 children received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg intranasal medication (midazolam),administering the drug was alternated between the two nostrils of the child, with a maximum dose of 10 mg via a spray of 0.2 ml per puff. |
| C (Placebo) | Placebo comparator | Drug: Placebo21 children received intranasal medication (saline 9% as placebo), 0.5 mg/kg, with a maximum dose of 10 mg via a spray of 0.2 ml per puff,administering the drug was alternated between the two nostrils of the child. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- uncooperative children scored 1 or 2 on Frankle Scale.
- had no medical history of neurological or cognitive alterations.
- No facial deformities.
- ASA Classification I.
- requiring dental treatment under local anesthesia.
Key exclusion criteria (2 listed)
- known allergy to midazolam or any other benzodiazepines.
- upper respiratory tract infection with nasal discharge.
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 |
|---|---|---|
| MidazolamAlso: APatients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS. | Drug | A (Midazolam) |
| Lidocaine-MidazolamAlso: BPatients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS. | Drug | B (Lidocaine-Midazolam) |
| PlaceboAlso: CPatients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS. | Drug | C (Placebo) |
Primary outcome
Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
Time frame: one to five minutes following the administration.
The use of intranasal midazolam is associated with a burning sensation of the nasal mucosa, the pain was assessed using a self report pain scale Wong Baker Faces Scale, the degree of pain is determined by choosing a score of (0-2-4-6-8-10) (minimum score 0, means no pain, maximum score 10, means the drug hurts worst, higher scores are worse) the scores were reported by children received intranasal midazolam alone, intranasal midazolam preceded by intranasal lidocaine or intranasal saline (placebo).
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 5 Nov 2018.
- Results publication: PubMed 27739142Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
- Individual participant dataSharing planned: Undecided. up to date, there is no decision about IPD sharing.
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.
Nabih Raslan, Dr. study chair
Latakia University
Walaa Khalil, Dr. principal investigator
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Midazolam and Lidocaine-Midazolam in people with Burning Nose, run by Latakia University at 1 site in Syria.
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 5 inclusion and 2 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 5 Nov 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 Syria. 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 combined 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.
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?
Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine . (time frame: one to five minutes following the administration.). 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 NCT03725995, 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 5 Nov 2018.