Procedural AnxietyPhase 3NCT04571879
Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children
A Phase 3 study testing Nebulized Lidocaine and Intranasal Midazolam in people with Procedural Anxiety and Procedural Pain, run by Hamad Medical Corporation at 2 sites in Qatar.
Trial summary
Nasogastric tube (NGT) is a commonly performed procedure in the Emergency Department. Although it is not a major procedure, it is usually associated with a bad experience and cause discomfort and pain in kids. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- Nebulized Lidocaine and Intranasal Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesQatar
- Study dates
- 25 Aug 2021to 28 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment.
Who cannot join
- Indication for an urgent insertion of a nasogastric tube.
- Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
- .Patients allergic to midazolam or lidocaine.
- .Congenital Heart disease or arrhythmia.
- .Known hepatic or renal impairment
- .Developmentally abnormal children
Show all 10Show fewer
- .Patients with seizure disorder
- .Pre-existing abnormal neurological conditions
- .Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline).
- .Known case of severe gastroesophageal reflux disease or aspiration pneumonia.
Trial locations and contacts
2 sites in 1 country.
Khalid Alansari contact
Qatar2 sites, 2 recruiting
- Recruiting
Pediatric Emergency Center, Hamad Medical Corporation
Doha, 3050
Fatihi Toaimah
- Not yet recruiting
Sidra Medicine
Doha, 3050
Khalid Alansari, MD
About this study
Official title: Nebulized Lidocaine and Intranasal Midazolam for Reducing Pain/Anxiety of Nasogastric Tube Insertion in Children: A Randomized Clinical Trial
Nasogastric tube (NGT) is a commonly performed procedure in the Emergency Department. Although it is not a major procedure, it is usually associated with a bad experience and cause discomfort and pain in kids. This randomized controlled double-blinded double-dummy trial aims to investigate the efficacy of local topical anesthetic and/or anxiolysis for pain/anxiety related to NGT insertion. Eligible patients are children with gastroenteritis aged 6 months to 5 years requiring NGT rehydration. The intervention are 3 arms of nebulized lidocaine with midazolam compared to nebulized midazolam alone or placebo. The primary outcome is procedure-related pain assessment using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during final NGT insertion attempt.
Read the detailed description
Nasogastric tube (NGT) insertion is commonly performed in the emergency department (ED) which can cause some pain/anxiety [Shih S and Rosen P, 2018]. The pain/discomfort related to NGT insertion comes from anxiety, gagging and sensitivity of nasopharynx and oropharynx [Tapiawala SN et al, 2008]. Success rate depends on cooperation, which limits order for nasogastric tube insertion in most patients especially in non-pediatric hospitals.
The pain and anxiety associated with such procedures in kids is a source of noxious stimuli to the nervous system. Not only does pain have a negative impact on neurological development, but children whose pain has not been adequately treated in infancy or early childhood reported lower pain thresholds as adolescents and adults [Ruda M.A.et al, 2000]. If not addressed, this pain can lead to distress for children, their parents and those performing the procedures, preprocedural anxiety in the future and can result in negative long-term emotional outcomes [Blount R.L et al,2006; Brewer S.G. et al, 2006].
Nebulized 2% lidocaine at doses of 4 and 8 mg/kg has shown to be safe in infants and children, with all blood levels obtained were well below the toxic range [Gjonaj S et al, 1997]. Nebulized lidocaine in doses up to 8 mg/kg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy [Gjonaj S et al, 1997]. Nebulized/intranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children [Babl FE et al,2009; Craig SS et al, 2019]. On the other hand it greatly reduced discomfort associated with NG tube in adult population [Cullen L et al, 2004]. This might be explained by the anxiety and lack of cooperation, especially in young kids, which might limit the validity of pain score during the whole procedure.
Midazolam has a controlled sedation with a quicker recovery time. The safety and tolerability profile of midazolam in pediatric patients is comparable/superior to that observed in adults [Pacifici GM, 2014]. Midazolam is a GABA receptor agonist providing anxiolysis for procedures in pediatric population. Midazolam has been shown to be safe and effective for use in children [Wilton NC et al,1988; Theroux MC et al, 1993]. Intranasal midazolam has shown improvements with anxiety and crying, as well as need for restraint [Theroux MC et al, 1993]. Midazolam anxiolysis has been tried in pediatrics and ordered as nebulization, found to have a plasma concentration bioavailability which is comparable to the intranasal midazolam by the ratio (nebulized:nasal) of 1:2.9. [McCormick AS et al, 2008]. Clinically effective serum concentrations of intranasal midazolam can be reached within less than 10 min after nasal application [Knoester PD et al, 2002].
Lidocaine / Midazolam has been commonly used in different procedures in pediatric emergency department; such as urethral catheterization, intravenous cannulation, lumbar puncture with a great safety margin.
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- Nebulized Lidocaine, Intranasal Midazolam, Placebo
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized LidocaineDrug
Also called Nebulized Xylocaine
Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children
Intranasal MidazolamDrug
Also called IN Midazolam
Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
PlaceboOther
Nebulized normal saline and intranasal normal sline
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Nebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr.
Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg). Receives: Drug: Nebulized Lidocaine; Drug: Intranasal Midazolam |
| Arm 2 | Experimental | Intranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg).
Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. Receives: Drug: Intranasal Midazolam |
| Arm 3 | Placebo comparator | Intranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization
Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity rating scale (FLACC) during insertion of NGT.
score from 0 to 10. Higher scores mean worse outcome
Measured: 1 year
Secondary outcomes (8)
Observer/caregiver pain severity rating:
Score from 1 to 100. Higher scores mean worse outcome
Measured: 1 year
The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.
Score from 1 to 5. Higher scores mean worse outcome
Measured: 1 year
The number of attempts required to successfully insert the NGT
The number of attempts of successful NGT insertion
Measured: 1 year
Procedural complications/adverse events.
Records complications and adverse effects
Measured: 1 year
FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.
Scores from 0 to 10. Higher scores mean worse outcome
Measured: up to 180 minutes
Length of stay in ED
Length of stay in minutes
Measured: up to 180 minutes
Duration of NGT feed.
The observer records data on chart
Measured: up to 180 minutes
Tolerated volume of NGT feed.
Amount of fluid (ml)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start25 Aug 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fatihi Toaimah, MD, PhD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571879
- Sponsor's protocol ID
- MRC-01-19-442
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shih S, Rosen P. Pain Management for Nasogastric Intubation in Pediatrics. Cureus. 2018 Oct 9;10(10):e3429. doi: 10.7759/cureus.3429.
PubMed 30555754Tapaiwala SN, Al Riyami D, Cole E. A painful and knotted nasogastric tube. CMAJ. 2008 Feb 26;178(5):568. doi: 10.1503/cmaj.070750. No abstract available.
PubMed 18299545Ruda MA, Ling QD, Hohmann AG, Peng YB, Tachibana T. Altered nociceptive neuronal circuits after neonatal peripheral inflammation. Science. 2000 Jul 28;289(5479):628-31. doi: 10.1126/science.289.5479.628.
PubMed 10915627Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.
PubMed 16330518Brewer S, Gleditsch SL, Syblik D, Tietjens ME, Vacik HW. Pediatric anxiety: child life intervention in day surgery. J Pediatr Nurs. 2006 Feb;21(1):13-22. doi: 10.1016/j.pedn.2005.06.004.
PubMed 16428010Gjonaj ST, Lowenthal DB, Dozor AJ. Nebulized lidocaine administered to infants and children undergoing flexible bronchoscopy. Chest. 1997 Dec;112(6):1665-9. doi: 10.1378/chest.112.6.1665.
PubMed 9404766Babl FE, Goldfinch C, Mandrawa C, Crellin D, O'Sullivan R, Donath S. Does nebulized lidocaine reduce the pain and distress of nasogastric tube insertion in young children? A randomized, double-blind, placebo-controlled trial. Pediatrics. 2009 Jun;123(6):1548-55. doi: 10.1542/peds.2008-1897.
PubMed 19482767Craig SS, Seith RW, Cheek JA, Wilson K, Egerton-Warburton D, Paul E, West A. Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial. Lancet Child Adolesc Health. 2019 Jun;3(6):391-397. doi: 10.1016/S2352-4642(19)30058-6. Epub 2019 Apr 15.
PubMed 31000379Cullen L, Taylor D, Taylor S, Chu K. Nebulized lidocaine decreases the discomfort of nasogastric tube insertion: a randomized, double-blind trial. Ann Emerg Med. 2004 Aug;44(2):131-7. doi: 10.1016/j.annemergmed.2004.03.033.
PubMed 15278085Pacifici GM. Clinical pharmacology of midazolam in neonates and children: effect of disease-a review. Int J Pediatr. 2014;2014:309342. doi: 10.1155/2014/309342. Epub 2014 Feb 18.
PubMed 24696691Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
PubMed 3195771Theroux MC, West DW, Corddry DH, Hyde PM, Bachrach SJ, Cronan KM, Kettrick RG. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics. 1993 Mar;91(3):624-7.
PubMed 8441570McCormick AS, Thomas VL, Berry D, Thomas PW. Plasma concentrations and sedation scores after nebulized and intranasal midazolam in healthy volunteers. Br J Anaesth. 2008 May;100(5):631-6. doi: 10.1093/bja/aen072. Epub 2008 Apr 2.
PubMed 18385262Knoester PD, Jonker DM, Van Der Hoeven RT, Vermeij TA, Edelbroek PM, Brekelmans GJ, de Haan GJ. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol. 2002 May;53(5):501-7. doi: 10.1046/j.1365-2125.2002.01588.x.
PubMed 11994056
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Lidocaine and Intranasal Midazolam for Reducing Pain/Anxiety of Nasogastric Tube Insertion in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04571879
- Acronym / sponsor ID
- MRC-01-19-442
- Conditions
- Procedural Anxiety, Procedural Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 1 Oct 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.
Nasogastric tube (NGT) is a commonly performed procedure in the Emergency Department. Although it is not a major procedure, it is usually associated with a bad experience and cause discomfort and pain in kids. This randomized controlled double-blinded double-dummy trial aims to investigate the efficacy of local topical anesthetic and/or anxiolysis for pain/anxiety related to NGT insertion. Eligible patients are children with gastroenteritis aged 6 months to 5 years requiring NGT rehydration. The intervention are 3 arms of nebulized lidocaine with midazolam compared to nebulized midazolam alone or placebo. The primary outcome is procedure-related pain assessment using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during final NGT insertion attempt.
Detailed description
Nasogastric tube (NGT) insertion is commonly performed in the emergency department (ED) which can cause some pain/anxiety [Shih S and Rosen P, 2018]. The pain/discomfort related to NGT insertion comes from anxiety, gagging and sensitivity of nasopharynx and oropharynx [Tapiawala SN et al, 2008]. Success rate depends on cooperation, which limits order for nasogastric tube insertion in most patients especially in non-pediatric hospitals.
The pain and anxiety associated with such procedures in kids is a source of noxious stimuli to the nervous system. Not only does pain have a negative impact on neurological development, but children whose pain has not been adequately treated in infancy or early childhood reported lower pain thresholds as adolescents and adults [Ruda M.A.et al, 2000]. If not addressed, this pain can lead to distress for children, their parents and those performing the procedures, preprocedural anxiety in the future and can result in negative long-term emotional outcomes [Blount R.L et al,2006; Brewer S.G. et al, 2006].
Nebulized 2% lidocaine at doses of 4 and 8 mg/kg has shown to be safe in infants and children, with all blood levels obtained were well below the toxic range [Gjonaj S et al, 1997]. Nebulized lidocaine in doses up to 8 mg/kg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy [Gjonaj S et al, 1997]. Nebulized/intranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children [Babl FE et al,2009; Craig SS et al, 2019]. On the other hand it greatly reduced discomfort associated with NG tube in adult population [Cullen L et al, 2004]. This might be explained by the anxiety and lack of cooperation, especially in young kids, which might limit the validity of pain score during the whole procedure.
Midazolam has a controlled sedation with a quicker recovery time. The safety and tolerability profile of midazolam in pediatric patients is comparable/superior to that observed in adults [Pacifici GM, 2014]. Midazolam is a GABA receptor agonist providing anxiolysis for procedures in pediatric population. Midazolam has been shown to be safe and effective for use in children [Wilton NC et al,1988; Theroux MC et al, 1993]. Intranasal midazolam has shown improvements with anxiety and crying, as well as need for restraint [Theroux MC et al, 1993]. Midazolam anxiolysis has been tried in pediatrics and ordered as nebulization, found to have a plasma concentration bioavailability which is comparable to the intranasal midazolam by the ratio (nebulized:nasal) of 1:2.9. [McCormick AS et al, 2008]. Clinically effective serum concentrations of intranasal midazolam can be reached within less than 10 min after nasal application [Knoester PD et al, 2002].
Lidocaine / Midazolam has been commonly used in different procedures in pediatric emergency department; such as urethral catheterization, intravenous cannulation, lumbar puncture with a great safety margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nebulized Lidocaine, Drug: Intranasal MidazolamNebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr. Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg). |
| Arm 2 | Experimental | Drug: Intranasal MidazolamIntranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg). Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. |
| Arm 3 | Placebo comparator | Other: PlaceboIntranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment.
Key exclusion criteria (10 listed)
- Indication for an urgent insertion of a nasogastric tube.
- Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
- .Patients allergic to midazolam or lidocaine.
- .Congenital Heart disease or arrhythmia.
- .Known hepatic or renal impairment
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 |
|---|---|---|
| Nebulized LidocaineAlso: Nebulized XylocaineNebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children | Drug | Arm 1 |
| Intranasal MidazolamAlso: IN MidazolamIntranasal Midazolam for reducing anxiety of Nasogastric Tube insertion | Drug | Arm 1, Arm 2 |
| PlaceboNebulized normal saline and intranasal normal sline | Other | Arm 3 |
Primary outcome
Pain severity rating scale (FLACC) during insertion of NGT.
Time frame: 1 year
score from 0 to 10. Higher scores mean worse outcome
8 secondary outcomes
Observer/caregiver pain severity rating:
Time frame: 1 year
The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.
Time frame: 1 year
The number of attempts required to successfully insert the NGT
Time frame: 1 year
Procedural complications/adverse events.
Time frame: 1 year
FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.
Time frame: up to 180 minutes
Length of stay in ED
Time frame: up to 180 minutes
Duration of NGT feed.
Time frame: up to 180 minutes
Tolerated volume of NGT feed.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 30555754Shih S, Rosen P. Pain Management for Nasogastric Intubation in Pediatrics. Cureus. 2018 Oct 9;10(10):e3429. doi: 10.7759/cureus.3429.
- Results publication: PubMed 18299545Tapaiwala SN, Al Riyami D, Cole E. A painful and knotted nasogastric tube. CMAJ. 2008 Feb 26;178(5):568. doi: 10.1503/cmaj.070750. No abstract available.
- Results publication: PubMed 10915627Ruda MA, Ling QD, Hohmann AG, Peng YB, Tachibana T. Altered nociceptive neuronal circuits after neonatal peripheral inflammation. Science. 2000 Jul 28;289(5479):628-31. doi: 10.1126/science.289.5479.628.
- Results publication: PubMed 16330518Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.
- Results publication: PubMed 16428010Brewer S, Gleditsch SL, Syblik D, Tietjens ME, Vacik HW. Pediatric anxiety: child life intervention in day surgery. J Pediatr Nurs. 2006 Feb;21(1):13-22. doi: 10.1016/j.pedn.2005.06.004.
- Results publication: PubMed 9404766Gjonaj ST, Lowenthal DB, Dozor AJ. Nebulized lidocaine administered to infants and children undergoing flexible bronchoscopy. Chest. 1997 Dec;112(6):1665-9. doi: 10.1378/chest.112.6.1665.
- Results publication: PubMed 19482767Babl FE, Goldfinch C, Mandrawa C, Crellin D, O'Sullivan R, Donath S. Does nebulized lidocaine reduce the pain and distress of nasogastric tube insertion in young children? A randomized, double-blind, placebo-controlled trial. Pediatrics. 2009 Jun;123(6):1548-55. doi: 10.1542/peds.2008-1897.
- Results publication: PubMed 31000379Craig SS, Seith RW, Cheek JA, Wilson K, Egerton-Warburton D, Paul E, West A. Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial. Lancet Child Adolesc Health. 2019 Jun;3(6):391-397. doi: 10.1016/S2352-4642(19)30058-6. Epub 2019 Apr 15.
- Results publication: PubMed 15278085Cullen L, Taylor D, Taylor S, Chu K. Nebulized lidocaine decreases the discomfort of nasogastric tube insertion: a randomized, double-blind trial. Ann Emerg Med. 2004 Aug;44(2):131-7. doi: 10.1016/j.annemergmed.2004.03.033.
- Results publication: PubMed 24696691Pacifici GM. Clinical pharmacology of midazolam in neonates and children: effect of disease-a review. Int J Pediatr. 2014;2014:309342. doi: 10.1155/2014/309342. Epub 2014 Feb 18.
- Results publication: PubMed 3195771Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
- Results publication: PubMed 8441570Theroux MC, West DW, Corddry DH, Hyde PM, Bachrach SJ, Cronan KM, Kettrick RG. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics. 1993 Mar;91(3):624-7.
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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.
Khalid Alansari contact
Fatihi Toaimah, MD, PhD principal investigator
Hamad Medical Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebulized Lidocaine and Intranasal Midazolam in people with Procedural Anxiety and Procedural Pain, run by Hamad Medical Corporation at 2 sites in Qatar.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatihi HS Toaimah, PhD (+97455628632, ftoaimah@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity rating scale (FLACC) during insertion of NGT. (time frame: 1 year). 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 NCT04571879, which also lists 14 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 2 Mar 2023.