Trial Outcomes & Findings for A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants (NCT NCT02395185)

Last Updated: 2017-12-15

Results Overview

Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to \>4 severe pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.

Results posted on

2017-12-15

Participant Flow

53 participants were assessed for eligability. 33 patient participants and their guardians were enrolled in the study from 3/13/13 to 9/17/14 at their initial clinical visit. A total of 131 casts were performed.

Participant milestones

Participant milestones
Measure	All Participants 33 Participants were randomized to one of 18 sequences of milk, water, or formula for an average of 6 casting visits.
Overall Study STARTED	33
Overall Study Sequence 1 (s,s,m,m,w,w)	2
Overall Study Sequence 2 (w,s,s,m,m,w)	2
Overall Study Sequence 3 (w,w,s,s,m,m)	2
Overall Study Sequence 4 (m,w,w,s,s,m)	2
Overall Study Sequence 5 (m,m,w,w,s,s)	2
Overall Study Sequence 6 (s,m,m,w,w,s)	2
Overall Study Sequence 7 (s,s,w,w,m,m)	2
Overall Study Sequence 8 (m,s,s,w,w,m)	2
Overall Study Sequence 9 (m,m,s,s,w,w)	2
Overall Study Sequence 10 (w,m,m,s,s,w)	2
Overall Study Sequence 11 (w,w,m,m,s,s)	2
Overall Study Sequence 12 (s,w,w,m,m,s)	2
Overall Study Sequence 13 (s,m,w,m,s,w)	2
Overall Study Sequence 14 (w,s,m,w,m,s)	2
Overall Study Sequence 15 (s,w,s,m,w,m)	2
Overall Study Sequence 16 (m,s,w,s,m,w)	1
Overall Study Sequence 17 (w,m,s,w,s,m)	1
Overall Study Sequence 18 (m,w,m,s,w,s)	1
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=33 Participants Bottle Administration: 2 oz of sucrose, water, or milk/formula given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.
Age, Customized <=18 years	33 participants n=5 Participants
Age, Customized Between 18 and 65 years	0 participants n=5 Participants
Age, Customized >=65 years	0 participants n=5 Participants
Age, Continuous	17.9 days STANDARD_DEVIATION 20.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.

Population: Because this was a crossover design, multiple casts were assessed for each participant

Outcome measures

Outcome measures
Measure	Milk n=37 casts Bottle Administration: 2 oz milk or formula given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Water n=39 casts Bottle Administration: 2 oz water given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Sucrose n=43 casts Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.
NIPS (Neonatal Infant Pain Scale) NIPS pre casting	2.28 units on a scale Standard Deviation 2.38	1.63 units on a scale Standard Deviation 2.12	1.84 units on a scale Standard Deviation 2.18
NIPS (Neonatal Infant Pain Scale) NIPS casting	0.91 units on a scale Standard Deviation 1.26	2.22 units on a scale Standard Deviation 2.01	0.63 units on a scale Standard Deviation 1.27
NIPS (Neonatal Infant Pain Scale) NIPS post casting	2.11 units on a scale Standard Deviation 2.37	1.49 units on a scale Standard Deviation 2.29	0.69 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.

Population: Because this was a crossover design, multiple casts were assessed for each participant

Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.

Outcome measures

Outcome measures
Measure	Milk n=37 casts Bottle Administration: 2 oz milk or formula given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Water n=39 casts Bottle Administration: 2 oz water given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Sucrose n=43 casts Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.
Heart Rate pre casting	152.72 bpm Standard Deviation 20.45	145.69 bpm Standard Deviation 17.12	155.9 bpm Standard Deviation 15.71
Heart Rate casting	152.54 bpm Standard Deviation 12.87	152.59 bpm Standard Deviation 9.03	154.33 bpm Standard Deviation 24.55
Heart Rate post casting	147.2 bpm Standard Deviation 12.05	143.89 bpm Standard Deviation 13.06	149.78 bpm Standard Deviation 12.99

SECONDARY outcome

Timeframe: Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting

Population: Because this was a crossover design, multiple casts were assessed for each participant

Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.

Outcome measures

Outcome measures
Measure	Milk n=37 casts Bottle Administration: 2 oz milk or formula given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Water n=39 casts Bottle Administration: 2 oz water given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Sucrose n=43 casts Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.
Oxygen Saturation post casting	98.07 percentage of SpO2 Standard Deviation 2.07	97.85 percentage of SpO2 Standard Deviation 2.34	98.18 percentage of SpO2 Standard Deviation 1.62
Oxygen Saturation pre casting	98 percentage of SpO2 Standard Deviation 1.57	97.52 percentage of SpO2 Standard Deviation 2.26	98.33 percentage of SpO2 Standard Deviation 1.63
Oxygen Saturation casting	97.38 percentage of SpO2 Standard Deviation 1.26	97.56 percentage of SpO2 Standard Deviation 3.23	94.32 percentage of SpO2 Standard Deviation 12.43

Adverse Events

Sucrose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Milk or Formula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sucrose n=29 participants at risk Bottle Administration: 2 oz sucrose solution given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Milk or Formula n=26 participants at risk Bottle Administration: 2 oz milk or formula given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.	Water n=26 participants at risk Bottle Administration: 2 oz water given in a bottle during the casting process Bottle Administration: Patients are given a bottle during the casting process. Contents of bottle depend on the arm to which they are randomized.
Gastrointestinal disorders Gastrointestinal disorder	3.4% 1/29 • Number of events 1 • up to four weeks after study participation Patients were monitored for gastrointestinal, systemic, or allergic reactions during routine clinical follow-up visits.	0.00% 0/26 • up to four weeks after study participation Patients were monitored for gastrointestinal, systemic, or allergic reactions during routine clinical follow-up visits.	0.00% 0/26 • up to four weeks after study participation Patients were monitored for gastrointestinal, systemic, or allergic reactions during routine clinical follow-up visits.

Additional Information

Rebecca Davis

Shriners Hospital for Children

Phone: 859-268-5705

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place