Trial Outcomes & Findings for Lidocaine Analgesia for Urethral Catheterization in Children (NCT NCT01780324)

Last Updated: 2016-04-11

Results Overview

Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

At time of procedure (up to 30 seconds after catheter insertion)

Results posted on

2016-04-11

Participant Flow

Dates of recruitment: 1/30/2013 through 4/27/2014 Location of recruitment: Emergency Department

All patients consented were randomized. 186 patients were screened 106 were excluded (41 did not meet inclusion criteria, 52 families declined participation, 13 medical team declined participation, 1 family refused catheterization 80 patients enrolled and randomized

Participant milestones

Participant milestones
Measure	No Lidocaine This group will have urinary catheterization without lidocaine (per standard procedure)	Lidocaine This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization. Lidocaine gel
Overall Study STARTED	41	39
Overall Study COMPLETED	40	33
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Analgesia for Urethral Catheterization in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Lidocaine n=41 Participants This group will have urinary catheterization without lidocaine (per standard procedure)	Lidocaine n=39 Participants This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization. Lidocaine gel	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=39 Participants	39 Participants n=41 Participants	80 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	12 months STANDARD_DEVIATION 8.1 • n=39 Participants	13 months STANDARD_DEVIATION 8.5 • n=41 Participants	12 months STANDARD_DEVIATION 8.3 • n=35 Participants
Sex: Female, Male Female	24 Participants n=39 Participants	24 Participants n=41 Participants	48 Participants n=35 Participants
Sex: Female, Male Male	17 Participants n=39 Participants	15 Participants n=41 Participants	32 Participants n=35 Participants
Region of Enrollment United States	41 participants n=39 Participants	39 participants n=41 Participants	80 participants n=35 Participants

PRIMARY outcome

Timeframe: At time of procedure (up to 30 seconds after catheter insertion)

Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.

Outcome measures

Outcome measures
Measure	No Lidocaine n=40 Participants This group will have urinary catheterization without lidocaine (per standard procedure)	Lidocaine n=33 Participants This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization. Lidocaine gel
Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale	9 units on a scale Interval 8.0 to 10.0	8 units on a scale Interval 7.0 to 9.0

Adverse Events

No Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine

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

Neil Uspal, MD

Seattle Children's Hospital

Phone: 206-987-2599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place