Adults 6 Months to 7, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Procedural Distress, OSBD-RPrimary· 10 minutes
The Observational Scale of Behavioral Distress-Revised (OSBD-R) is an observational measure of pain and distress shown to have strong validity in children. The scale is an 8-factor, weighted observational scale used to measure distress associated with medical procedures, which has been validated in children and adults aged 1 to 20 years. The total Observational Scale of Behavioral Distress-Revised score is the sum of the scale scores for each phase, with each phase assigned a score from 0 to 23.5 units on a scale (0=no distress, 23.5=maximum distress), based on the frequency and types of behav
Group
Value
95% CI
PREMED
6.4
5 – 7.8
PREMIX
7
5.2 – 8.9
Procedural PainSecondary· 10 minutes
The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) utilizes six observational factors (cry, facial, verbal, torso, touch, and legs) to evaluate pain in young children and can be used to monitor the effectiveness of interventions for reducing the pain and discomfort of an intervention. This scale rates each behavior numerically, with a score of 4-6 units on a scale representing no pain, and a maximum score of 13 units on a scale representing (most pain perceived).
Group
Value
95% CI
PREMED
10.6
9.7 – 11.4
PREMIX
10.5
9.5 – 11.4
Procedural Distress, FLACCSecondary· 10 minutes
The Faces, Legs, Activity, Cry, Consolability (FLACC) scale is comprised of five criteria (face, legs, activity, cry, consolability), with a possible score of 0 to 2 units on a scale for each criteria and a possible total score of 0 to 10 units on a scale (0 meaning no pain, 10 meaning most pain).
Cry duration was measured in seconds and defined as the time from onset of crying following administration of an IN medication until the cessation of crying sounds and/or tears. If a patient did not cry, the cry duration was zero
Group
Value
95% CI
PREMED
84
58 – 109
PREMIX
73
45 – 102
Parental SatisfactionSecondary· 1 minute
If my child needed medications to stay calm for a procedure, I would like to use these same medications again.
Group
Value
95% CI
PREMED
10
PREMIX
12
Provider SatisfactionSecondary· 1 minute
I would like to use this method of administering intranasal midazolam and lidocaine again in the future
Group
Value
95% CI
PREMED
8
PREMIX
24
Adverse events — posted to ClinicalTrials.gov
Time frame: Course of ED visit, typically between 1-2 hours.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and distressing procedures, such as laceration repairs. Intranasal midazolam is both effective and safe in children. However, due to the acidic nature of midazolam, there is a burning sensation that is associated with the intranasal administration of midazolam. The use of IN lidocaine has been shown to decrease the pain associated with the administration of IN midazolam and other acidic solutions. The IN lidocaine can be given as a premedication (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then followed by the administration of the IN midazolam. Lidocaine can also be given concurrently with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined mixture administered. Both methods have been shown to be effective in decreasing the pain associated with the intranasal administration of acidic solutions, such as midazolam, although the PREMIX method could have the advantage of requiring less number of sprays, and be tolerated better by children. Although both methods have been shown to work, it is not known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and distress associated with administering IN midazolam. Therefore, the investigators aim to determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to decrease the pain and distress associated with the administration of IN midazolam in children.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07488832 — Intravenous Lidocaine Infusion in Lumbar Fusion Surgery
· NA
· recruiting
NCT07445191 — Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Contr
· Phase 2, PHASE3
· not yet recruiting
NCT07422558 — Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain
· NA
· not yet recruiting
NCT06923787 — Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patient
· Phase 2
· recruiting
NCT07355049 — The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.
· NA
· not yet recruiting
Other recruiting trials for Pain
Currently open trials in the same condition.
NCT07533409 — Tactile and Pain Sensory Thresholds and Hand Grip Strength
· recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging
· EARLY_PHASE1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 11 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03054844.