Postoperative Pain
Conditions
Brief summary
To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.
Detailed description
Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest PCA pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. No studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.
Interventions
DEVICEPatient-Controlled Analgesia pump with Cues
The end of the lockout period will be cued via the PCA pump
DEVICEPatient-Controlled Analgesia pump without Cues
The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.
DRUGMorphine
Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 7-18 years * Opioid naïve * Scheduled for a surgery for which a PCA is routinely used for post-operative pain management * At least 1 parent speaks English
Exclusion criteria
* Prior experience with PCA * Cognitive delay precluding independent use of the PCA button * Current use of anxiolytics or antidepressants * Patients receiving epidural analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Questionnaire | Up to 72 hours | Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Days [POD] 0 - 2, up to 72 hours | Total amount of opioid consumed post-operatively in mg/kg/hour. |
| Anxiety (State Anxiety on POD 1 and POD 2) | Up to 72 hours | State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10. |
Countries
United States
Participant flow
Recruitment details
Participants could not be recruited after surgery; therefore, all eligible participants were recruited, but not all received a PCA after surgery.
Participants by arm
| Arm | Count |
|---|---|
| Cues The PCA pump will be programmed to provide a cue to the end of the lockout period.
Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump
Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups | 64 |
| No Cues The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).
Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.
Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups | 61 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete the primary outcome | 0 | 1 |
| Overall Study | Did not receive allocated intervention | 24 | 26 |
Baseline characteristics
| Characteristic | Cues | No Cues | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 64 Participants | 61 Participants | 125 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11 years | 11 years | 11 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 52 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 48 Participants | 47 Participants | 95 Participants |
| Sex: Female, Male Female | 39 Participants | 38 Participants | 77 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 11 / 64 | 6 / 62 |
| serious Total, serious adverse events | 0 / 64 | 0 / 62 |
Outcome results
Primary
Patient Satisfaction Questionnaire
Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.
Time frame: Up to 72 hours
Population: Includes participants who completed the post-intervention survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cues | Patient Satisfaction Questionnaire | 8 units on a scale |
| No Cues | Patient Satisfaction Questionnaire | 7.5 units on a scale |
Secondary
Anxiety (State Anxiety on POD 1 and POD 2)
State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10.
Time frame: Up to 72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cues | Anxiety (State Anxiety on POD 1 and POD 2) | POD 2 | 53.5 units on a scale |
| Cues | Anxiety (State Anxiety on POD 1 and POD 2) | POD 1 | 55 units on a scale |
| No Cues | Anxiety (State Anxiety on POD 1 and POD 2) | POD 1 | 55 units on a scale |
| No Cues | Anxiety (State Anxiety on POD 1 and POD 2) | POD 2 | 52 units on a scale |
Secondary
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
Total amount of opioid consumed post-operatively in mg/kg/hour.
Time frame: Post-op Days [POD] 0 - 2, up to 72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 0 | 0.0252 mg/kg/hr |
| Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 1 | 0.0214 mg/kg/hr |
| Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 2 | 0.0162 mg/kg/hr |
| No Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 0 | 0.0248 mg/kg/hr |
| No Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 1 | 0.0163 mg/kg/hr |
| No Cues | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Post-op Day 2 | 0.0125 mg/kg/hr |