Trial Outcomes & Findings for Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration (NCT NCT02396537)

Last Updated: 2017-02-23

Results Overview

subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying "No Hurt") and a maximum score of 10 ("Hurts Worst"). Values between include 2 ("Hurts Little Bit"), 4 ("Hurts Little More"), 6 ("Hurts Even More"), and 8 ("Hurts Whole Lot."). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain).

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

immediately after administration of intranasal midazolam

Results posted on

2017-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Intranasal Lidocaine Patient to receive 4% lidocaine intranasally prior to midazolam Lidocaine: Administered intranasally prior to Midazolam administration. Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.	Intranasal 0.9% Saline Patient to receive 0.9% Saline intranasally prior to midazolam Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. 0.9% Saline: Administered intranasally prior to Midazolam administration.
Overall Study STARTED	40	37
Overall Study COMPLETED	40	36
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intranasal Lidocaine Patient to receive 4% lidocaine intranasally prior to midazolam Lidocaine: Administered intranasally prior to Midazolam administration. Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.	Intranasal 0.9% Saline Patient to receive 0.9% Saline intranasally prior to midazolam Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. 0.9% Saline: Administered intranasally prior to Midazolam administration.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Lidocaine n=40 Participants Patient to receive 4% lidocaine intranasally prior to midazolam Lidocaine: Administered intranasally prior to Midazolam administration. Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.	Intranasal 0.9% Saline n=36 Participants Patient to receive 0.9% Saline intranasally prior to midazolam Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. 0.9% Saline: Administered intranasally prior to Midazolam administration.	Total n=76 Participants Total of all reporting groups
Age, Continuous	8 years n=5 Participants	9 years n=7 Participants	8 years n=5 Participants
Gender Female	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Gender Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	36 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately after administration of intranasal midazolam

Outcome measures

Outcome measures
Measure	Intranasal Lidocaine n=40 Participants Subjects were administered 4% lidocaine solution, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (intervention group).	Intranasal 0.9% Saline n=36 Participants Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group).
Discomfort With Intranasal Midazolam Administration	3 units on a scale Interval 0.0 to 6.0	8 units on a scale Interval 2.0 to 9.0

Adverse Events

Intranasal Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intranasal 0.9% Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Pruitt

University of Alabama at Birmingham

Phone: 2056389587

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place