Trial Outcomes & Findings for The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures (NCT NCT01328782)

Results Overview

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

Will be obtained 30 - 60 minutes after arrival to the recovery room

Results posted on

2015-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Narcotic Group This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Overall Study STARTED	43	42	39
Overall Study COMPLETED	43	42	39
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Narcotic Group n=43 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=42 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=39 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	43 Participants n=5 Participants	42 Participants n=7 Participants	39 Participants n=5 Participants	124 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	6.92 years STANDARD_DEVIATION 1.99 • n=5 Participants	6.86 years STANDARD_DEVIATION 1.74 • n=7 Participants	6.73 years STANDARD_DEVIATION 2.21 • n=5 Participants	6.85 years STANDARD_DEVIATION 1.97 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	70 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	42 participants n=7 Participants	39 participants n=5 Participants	124 participants n=4 Participants

PRIMARY outcome

Timeframe: Will be obtained 30 - 60 minutes after arrival to the recovery room

Population: Based on the number of participants that self-reported their pain score.

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

Outcome measures

Outcome measures
Measure	Oral Narcotic Group n=37 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=41 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=35 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).	4.14 Scores on a scale Standard Deviation 3.45	2.73 Scores on a scale Standard Deviation 3.28	3.66 Scores on a scale Standard Deviation 3.58

SECONDARY outcome

Timeframe: Will be obtained from parent(s) 120 minutes after arrival to the recovery room

Population: Based on number of participants and their parents/legal guardians that completed the survey.

Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.

Outcome measures

Outcome measures
Measure	Oral Narcotic Group n=38 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=37 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=37 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting	4.58 Scores on a scale Standard Deviation 3.40	2.73 Scores on a scale Standard Deviation 2.58	4.32 Scores on a scale Standard Deviation 3.22

SECONDARY outcome

Timeframe: first 72 hours after surgery close time

Population: All subjects were included in the analysis.

Outcome measures

Outcome measures
Measure	Oral Narcotic Group n=43 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=42 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=39 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Time (in Minutes) to First Narcotic Administration	30 Minutes Interval 20.5 to 53.5	50.5 Minutes Interval 30.5 to 115.3	34 Minutes Interval 21.5 to 56.5

SECONDARY outcome

Timeframe: Analgesic data collected during first four hours following the end of surgery (surgery close)

Population: All subjects were included in the analysis.

Outcome measures

Outcome measures
Measure	Oral Narcotic Group n=43 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=42 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=39 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge	0.09 Morphine (po) equivalents [mg*kg-1] Standard Deviation 0.09	0.05 Morphine (po) equivalents [mg*kg-1] Standard Deviation 0.05	0.08 Morphine (po) equivalents [mg*kg-1] Standard Deviation 0.09

SECONDARY outcome

Timeframe: First 120 minutes after the end of surgery (surgery close time)

Population: All subjects were included in the analysis.

Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.

Outcome measures

Outcome measures
Measure	Oral Narcotic Group n=43 Participants This group will receive Oxycodone with Acetaminophen orally	Bupivacaine Group n=42 Participants This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.	Ropivacaine Group n=39 Participants This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Need for IV Morphine of Fentanyl	19 participants	4 participants	15 participants

Adverse Events

Oral Narcotic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine Group

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

Gaia Georgopoulos, MD

Children's Hospital Colorado

Phone: 720-777-2588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place