Trial Outcomes & Findings for Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures (NCT NCT04003012)

Last Updated: 2023-03-09

Results Overview

Pain was self-reported by the child using the validated pain scale, Wong-Baker Faces Pain Rating Scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain, with higher the number, greater the pain. Below are the median and range of values (minimal to maximal) reported by each arm's 10 patients. Reported values were identical between arms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

, pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture

Results posted on

2023-03-09

Participant Flow

10 patients were screen and enrolled in the study

Participant milestones

Participant milestones
Measure	EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture First lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion.	Lidocaine Injection for First Lumbar Puncture, EMLA for Second Lumbar Puncture First lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture n=5 Participants First lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion.	Lidocaine Injection for First Lumbar Puncture, EMLA for Second Lumbar Puncture n=5 Participants First lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure.	Total n=10 Participants Total of all reporting groups
Age, Continuous	5 years n=5 Participants	6 years n=7 Participants	5.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture

Outcome measures

Outcome measures
Measure	EMLA n=10 Participants Participants who received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure, either the first or second lumbar puncture included in the study.	Lidocaine Injection n=10 Participants Participants who received sham-EMLA cream (applied at least 60 minutes prior to procedure) and following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) at the appropriate site 30-60 seconds prior to prior to procedure, either the first or second lumbar puncture included in the study.
Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale Wong-Baker Faces Pain Rating Scale Score 30 - 60 minutes after waking up after lumbar puncture	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0
Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale Wong-Baker Faces Pain Rating Scale Score 24 hours after lumbar puncture	0 score on a scale Interval 0.0 to 8.0	0 score on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 24 hours following lumbar puncture

Use of PRN or "as needed" pain medicine by the patient was determined. Patients with parent/guardian assistance were asked to record the "as needed" pain control medication, acetaminophen. the patient used within the 24 hours after lumber puncture. Counts of patients using acetaminophen in the 24 hours following lumber puncture are reported.

Outcome measures

Outcome measures
Measure	EMLA n=10 Participants Participants who received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure, either the first or second lumbar puncture included in the study.	Lidocaine Injection n=10 Participants Participants who received sham-EMLA cream (applied at least 60 minutes prior to procedure) and following conscious sedation, the patient received lidocaine 1% injection (\~1-2ml) at the appropriate site 30-60 seconds prior to prior to procedure, either the first or second lumbar puncture included in the study.
Post Lumbar Puncture PRN Pain Medication Usage	1 Participants	2 Participants

Adverse Events

EMLA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine Injection

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. Stephanie Thompson

CAMC Institute of Academic Medicine

Phone: 304-388-9911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place