The safety and efficacy of PRECEDEX has been evaluated in four randomized, double-blind, placebo-controlled multicenter clinical trials in 1,185 adult patients.
Two randomized, double-blind, parallel-group, placebo-controlled multicenter clinical trials included 754 adult patients being treated in a surgical intensive care unit. All patients were initially intubated and received mechanical ventilation. These trials evaluated the sedative properties of PRECEDEX by comparing the amount of rescue medication (midazolam in one trial and propofol in the second) required to achieve a specified level of sedation (using the standardized Ramsay Sedation Scale) between PRECEDEX and placebo from onset of treatment to extubation or to a total treatment duration of 24 hours. The Ramsay Level of Sedation Scale is displayed in Table 12.
| Clinical Score | Level of Sedation Achieved |
|---|---|
6 | Asleep, no response |
5 | Asleep, sluggish response to light glabellar tap or loud auditory stimulus |
4 | Asleep, but with brisk response to light glabellar tap or loud auditory stimulus |
3 | Patient responds to commands |
2 | Patient cooperative, oriented, and tranquil |
1 | Patient anxious, agitated, or restless |
In the first study, 175 adult patients were randomized to receive placebo and 178 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes. The study drug infusion rate was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive "rescue" midazolam as needed to augment the study drug infusion. In addition, morphine sulfate was administered for pain as needed. The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated. Patients randomized to placebo received significantly more midazolam than patients randomized to PRECEDEX (see Table 13).
A second prospective primary analysis assessed the sedative effects of PRECEDEX by comparing the percentage of adult patients who achieved a Ramsay sedation score of ≥3 during intubation without the use of additional rescue medication. A significantly greater percentage of adult patients in the PRECEDEX group maintained a Ramsay sedation score of ≥3 without receiving any midazolam rescue compared to the placebo group (see Table 13).
| Placebo (N = 175) | PRECEDEX (N = 178) | p-value | |
|---|---|---|---|
| ITT (intent-to-treat) population includes all randomized patients. | |||
Mean Total Dose (mg) of Midazolam | 19 mg | 5 mg | 0.0011* |
Standard deviation | 53 mg | 19 mg | |
Categorized Midazolam Use | |||
0 mg | 43 (25%) | 108 (61%) | <0.001† |
0–4 mg | 34 (19%) | 36 (20%) | |
>4 mg | 98 (56%) | 34 (19%) | |
A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.47 versus 0.83 mg/h). In addition, 44% (79 of 178 patients) of PRECEDEX patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.
In a second study, 198 adult patients were randomized to receive placebo and 203 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes. The study drug infusion was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive "rescue" propofol as needed to augment the study drug infusion. In addition, morphine sulfate was administered as needed for pain. The primary outcome measure for this study was the total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated.
Adult patients randomized to placebo received significantly more propofol than adult patients randomized to PRECEDEX (see Table 14).
A significantly greater percentage of adult patients in the PRECEDEX group compared to the placebo group maintained a Ramsay sedation score of ≥3 without receiving any propofol rescue (see Table 14).
| Placebo (N = 198) | PRECEDEX (N = 203) | p-value | |
|---|---|---|---|
Mean Total Dose (mg) of Propofol | 513 mg | 72 mg | <0.0001* |
Standard deviation | 782 mg | 249 mg | |
Categorized Propofol Use | |||
0 mg | 47 (24%) | 122 (60%) | <0.001† |
0–50 mg | 30 (15%) | 43 (21%) | |
>50 mg | 121 (61%) | 38 (19%) | |
A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.43 versus 0.89 mg/h). In addition, 41% (83 of 203 patients) of PRECEDEX patients received no morphine sulfate for pain versus 15% (30 of 198 patients) in the placebo group.
In a controlled clinical trial, PRECEDEX was compared to midazolam for ICU sedation exceeding 24 hours duration. PRECEDEX was not shown to be superior to midazolam for the primary efficacy endpoint, the percent of time patients were adequately sedated (81% versus 81%). In addition, administration of PRECEDEX for longer than 24 hours was associated with tolerance, tachyphylaxis, and a dose-related increase in adverse events [see Adverse Reactions (6.1)].
Adult Patients
The safety and efficacy of PRECEDEX for sedation of non-intubated adult patients prior to and/or during surgical and other procedures was evaluated in two randomized, double-blind, placebo-controlled multicenter clinical trials. Study 1 evaluated the sedative properties of PRECEDEX in adult patients having a variety of elective surgeries/procedures performed under monitored anesthesia care. Study 2 evaluated PRECEDEX in adult patients undergoing awake fiberoptic intubation prior to a surgical or diagnostic procedure.
In Study 1, the sedative properties of PRECEDEX were evaluated by comparing the percent of adult patients not requiring rescue midazolam to achieve a specified level of sedation using the standardized Observer's Assessment of Alertness/Sedation Scale (see Table 15).
| Assessment Categories | ||||
|---|---|---|---|---|
| Responsiveness | Speech | Facial Expression | Eyes | Composite Score |
Responds readily to name spoken in normal tone | Normal | Normal | Clear, no ptosis | 5 (alert) |
Lethargic response to name spoken in normal tone | Mild slowing or thickening | Mild relaxation | Glazed or mild ptosis (less than half the eye) | 4 |
Responds only after name is called loudly and/or repeatedly | Slurring or prominent slowing | Marked relaxation | Glazed and marked ptosis (half the eye or more) | 3 |
Responds only after mild prodding or shaking | Few recognizable words | – | – | 2 |
Does not respond to mild prodding or shaking | – | – | – | 1 (deep sleep) |
Adult patients were randomized to receive a loading infusion of either PRECEDEX 1 mcg/kg, PRECEDEX 0.5 mcg/kg, or placebo (normal saline) given over 10 minutes and followed by a maintenance infusion started at 0.6 mcg/kg/hr. The maintenance infusion of study drug could be titrated from 0.2 mcg/kg/hr to 1 mcg/kg/hr to achieve the targeted sedation score (Observer's Assessment of Alertness/Sedation Scale ≤4). Adult patients were allowed to receive rescue midazolam as needed to achieve and/or maintain an Observer's Assessment of Alertness/Sedation Scale ≤4. After achieving the desired level of sedation, a local or regional anesthetic block was performed. Demographic characteristics were similar between the PRECEDEX and comparator groups. Efficacy results showed that PRECEDEX was more effective than the comparator group when used to sedate non-intubated patients requiring monitored anesthesia care during surgical and other procedures (see Table 15).
In Study 2, the sedative properties of PRECEDEX were evaluated by comparing the percent of adult patients requiring rescue midazolam to achieve or maintain a specified level of sedation using the Ramsay Sedation Scale score ≥2 (see Table 12). Adult patients were randomized to receive a loading infusion of PRECEDEX 1 mcg/kg or placebo (normal saline) given over 10 minutes and followed by a fixed maintenance infusion of 0.7 mcg/kg/hr. After achieving the desired level of sedation, topicalization of the airway occurred. Adult patients were allowed to receive rescue midazolam as needed to achieve and/or maintain a Ramsay Sedation Scale ≥2. Demographic characteristics were similar between the PRECEDEX and comparator groups. For efficacy results see Table 16.
| Study | Loading Infusion Treatment Arm | Number of Patients Enrolled* | % Not Requiring Midazolam Rescue | Confidence† Interval on the Difference vs. Placebo | Mean (SD) Total Dose (mg) of Rescue Midazolam Required | Confidence† Intervals of the Mean Rescue Dose |
|---|---|---|---|---|---|---|
Study 1 | Dexmedetomidine | 134 | 40 | 37 (27, 48) | 1.4 (1.7) | -2.7 |
Dexmedetomidine | 129 | 54 |
| 0.9 (1.5) | -3.1 | |
Placebo | 63 | 3 | – | 4.1 (3.0) | – | |
Study 2 | Dexmedetomidine | 55 | 53 | 39 (20, 57) | 1.1 (1.5) | -1.8 |
Placebo | 50 |
| – | 2.9 (3.0) | – | |
Pediatric Patients
The safety and efficacy of PRECEDEX for sedation of non-intubated pediatric patients aged 1 month to less than 17 years undergoing MRI scans was evaluated in one randomized, double-blind, dose-ranging, dose‑controlled multicenter clinical trial utilizing 3 different PRECEDEX dosages. The sedative properties of PRECEDEX were evaluated by age group and by the percent of pediatric patients at the high dose level versus the low dose level who did not require concomitant propofol to complete the MRI scan.
A total of 122 pediatric patients were randomized to the PRECEDEX low dose group (42 of 122), the middle dose group (42 of 122) or the high dose treatment group (38 of 122). All patients received a PRECEDEX loading dose infusion over 10 minutes followed by a maintenance infusion for the duration of the MRI scan (Table 17). If an adequate level of sedation was not achieved within 5 minutes after the start of the PRECEDEX maintenance infusion, patients could receive concomitant propofol as needed based on clinical judgment to achieve and/or maintain adequate sedation.
High Dose | Middle Dose | Low Dose | ||||
Age | Loading Dose (10 min) | Maintenance Dose | Loading Dose (10 min) | Maintenance Dose | Loading Dose (10 min) | Maintenance Dose |
1 month to less than 2 years | 1.5 mcg/kg | 1.5 mcg/kg/h | 1 mcg/kg | 1 mcg/kg/h | 0.5 mcg/kg | 0.5 mcg/kg/h |
2 to less than 17 years | 2 mcg/kg | 1.5 mcg/kg/h | 1.2 mcg /kg | 1 mcg/kg/h | 0.5 mcg/kg | 0.5 mcg kg/h |
The primary efficacy results from this pediatric procedural sedation study are summarized in Table 18. In the combined age group, the percent of pediatric patients not requiring concomitant propofol was 14.3% (6/42) in the low dose group and 63.2% (24/38) in the high dose group. The percentage of patients at the PRECEDEX high dose who completed the MRI without concomitant propofol was statistically greater than the percentage in the PRECEDEX low dose group (p<0.001).
Age Group | High Dose | Middle Dose | Low Dose | High Dose vs Low Dose | ||
n (%) 95% CI* | n (%) 95% CI* | n (%) 95% CI* | Odds Ratio 95% CI† | p-value† | ||
1 month to less than 2 years | N=59 | 9/18 (50.0%) (0.26, 0.74) | 2/21 (9.5%) (0.01, 0.30) | 2/20 (15.0%) (0.03, 0.38) | 0.18 (0.04, 0.82) | 0.022 |
2 to less than 17 years | N=63 | 15/20 (75.0%) (0.51, 0.91) | 13/21 (61.9%) (0.38, 0.82) | 3/22 (13.6%) (0.03, 0.35) | 0.05 (0.01, 0.26) | <0.001 |
Overall | N=122 | 24/38 (63.2%) (0.46, 0.78) | 15/42 (35.7%) (0.22, 0.52) | 6/42 (14.3%) (0.05, 0.29) | 0.10 (0.03, 0.29) | <0.001 |
Secondarily, the sedative properties were also evaluated by examining the percent of time at a target sedation score using the Pediatric Sedation State Scale (PSSS). The PSSS is a validated 6-point scale specifically designed for evaluating pediatric patients undergoing sedation for diagnostic and therapeutic procedures. The PSSS measures the effectiveness and quality of procedural sedation in children. The target sedation level was indicated by a PSSS score of 2 (i.e., patient is quiet [asleep or awake], not moving during procedure, has no frown [or brow furrow] indicating pain or anxiety and no verbalization of any complaint).
In the PRECEDEX high dose group, pediatric patients in both the combined and individual age group were at the target sedation rating scale score (PSSS of 2) for a mean >87% of the time during the PRECEDEX maintenance infusion. In both the combined and individual age group, an increase in the percentage of time at the target sedation rating scale score (PSSS of 2) was observed with increasing PRECEDEX dosage.
The safety and efficacy of PRECEDEX has been evaluated in four randomized, double-blind, placebo-controlled multicenter clinical trials in 1,185 adult patients.
Two randomized, double-blind, parallel-group, placebo-controlled multicenter clinical trials included 754 adult patients being treated in a surgical intensive care unit. All patients were initially intubated and received mechanical ventilation. These trials evaluated the sedative properties of PRECEDEX by comparing the amount of rescue medication (midazolam in one trial and propofol in the second) required to achieve a specified level of sedation (using the standardized Ramsay Sedation Scale) between PRECEDEX and placebo from onset of treatment to extubation or to a total treatment duration of 24 hours. The Ramsay Level of Sedation Scale is displayed in Table 12.
| Clinical Score | Level of Sedation Achieved |
|---|---|
6 | Asleep, no response |
5 | Asleep, sluggish response to light glabellar tap or loud auditory stimulus |
4 | Asleep, but with brisk response to light glabellar tap or loud auditory stimulus |
3 | Patient responds to commands |
2 | Patient cooperative, oriented, and tranquil |
1 | Patient anxious, agitated, or restless |
In the first study, 175 adult patients were randomized to receive placebo and 178 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes. The study drug infusion rate was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive "rescue" midazolam as needed to augment the study drug infusion. In addition, morphine sulfate was administered for pain as needed. The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated. Patients randomized to placebo received significantly more midazolam than patients randomized to PRECEDEX (see Table 13).
A second prospective primary analysis assessed the sedative effects of PRECEDEX by comparing the percentage of adult patients who achieved a Ramsay sedation score of ≥3 during intubation without the use of additional rescue medication. A significantly greater percentage of adult patients in the PRECEDEX group maintained a Ramsay sedation score of ≥3 without receiving any midazolam rescue compared to the placebo group (see Table 13).
| Placebo (N = 175) | PRECEDEX (N = 178) | p-value | |
|---|---|---|---|
| ITT (intent-to-treat) population includes all randomized patients. | |||
Mean Total Dose (mg) of Midazolam | 19 mg | 5 mg | 0.0011* |
Standard deviation | 53 mg | 19 mg | |
Categorized Midazolam Use | |||
0 mg | 43 (25%) | 108 (61%) | <0.001† |
0–4 mg | 34 (19%) | 36 (20%) | |
>4 mg | 98 (56%) | 34 (19%) | |
A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.47 versus 0.83 mg/h). In addition, 44% (79 of 178 patients) of PRECEDEX patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.
In a second study, 198 adult patients were randomized to receive placebo and 203 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes. The study drug infusion was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive "rescue" propofol as needed to augment the study drug infusion. In addition, morphine sulfate was administered as needed for pain. The primary outcome measure for this study was the total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated.
Adult patients randomized to placebo received significantly more propofol than adult patients randomized to PRECEDEX (see Table 14).
A significantly greater percentage of adult patients in the PRECEDEX group compared to the placebo group maintained a Ramsay sedation score of ≥3 without receiving any propofol rescue (see Table 14).
| Placebo (N = 198) | PRECEDEX (N = 203) | p-value | |
|---|---|---|---|
Mean Total Dose (mg) of Propofol | 513 mg | 72 mg | <0.0001* |
Standard deviation | 782 mg | 249 mg | |
Categorized Propofol Use | |||
0 mg | 47 (24%) | 122 (60%) | <0.001† |
0–50 mg | 30 (15%) | 43 (21%) | |
>50 mg | 121 (61%) | 38 (19%) | |
A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.43 versus 0.89 mg/h). In addition, 41% (83 of 203 patients) of PRECEDEX patients received no morphine sulfate for pain versus 15% (30 of 198 patients) in the placebo group.
In a controlled clinical trial, PRECEDEX was compared to midazolam for ICU sedation exceeding 24 hours duration. PRECEDEX was not shown to be superior to midazolam for the primary efficacy endpoint, the percent of time patients were adequately sedated (81% versus 81%). In addition, administration of PRECEDEX for longer than 24 hours was associated with tolerance, tachyphylaxis, and a dose-related increase in adverse events [see Adverse Reactions (6.1)].
Adult Patients
The safety and efficacy of PRECEDEX for sedation of non-intubated adult patients prior to and/or during surgical and other procedures was evaluated in two randomized, double-blind, placebo-controlled multicenter clinical trials. Study 1 evaluated the sedative properties of PRECEDEX in adult patients having a variety of elective surgeries/procedures performed under monitored anesthesia care. Study 2 evaluated PRECEDEX in adult patients undergoing awake fiberoptic intubation prior to a surgical or diagnostic procedure.
In Study 1, the sedative properties of PRECEDEX were evaluated by comparing the percent of adult patients not requiring rescue midazolam to achieve a specified level of sedation using the standardized Observer's Assessment of Alertness/Sedation Scale (see Table 15).
| Assessment Categories | ||||
|---|---|---|---|---|
| Responsiveness | Speech | Facial Expression | Eyes | Composite Score |
Responds readily to name spoken in normal tone | Normal | Normal | Clear, no ptosis | 5 (alert) |
Lethargic response to name spoken in normal tone | Mild slowing or thickening | Mild relaxation | Glazed or mild ptosis (less than half the eye) | 4 |
Responds only after name is called loudly and/or repeatedly | Slurring or prominent slowing | Marked relaxation | Glazed and marked ptosis (half the eye or more) | 3 |
Responds only after mild prodding or shaking | Few recognizable words | – | – | 2 |
Does not respond to mild prodding or shaking | – | – | – | 1 (deep sleep) |
Adult patients were randomized to receive a loading infusion of either PRECEDEX 1 mcg/kg, PRECEDEX 0.5 mcg/kg, or placebo (normal saline) given over 10 minutes and followed by a maintenance infusion started at 0.6 mcg/kg/hr. The maintenance infusion of study drug could be titrated from 0.2 mcg/kg/hr to 1 mcg/kg/hr to achieve the targeted sedation score (Observer's Assessment of Alertness/Sedation Scale ≤4). Adult patients were allowed to receive rescue midazolam as needed to achieve and/or maintain an Observer's Assessment of Alertness/Sedation Scale ≤4. After achieving the desired level of sedation, a local or regional anesthetic block was performed. Demographic characteristics were similar between the PRECEDEX and comparator groups. Efficacy results showed that PRECEDEX was more effective than the comparator group when used to sedate non-intubated patients requiring monitored anesthesia care during surgical and other procedures (see Table 15).
In Study 2, the sedative properties of PRECEDEX were evaluated by comparing the percent of adult patients requiring rescue midazolam to achieve or maintain a specified level of sedation using the Ramsay Sedation Scale score ≥2 (see Table 12). Adult patients were randomized to receive a loading infusion of PRECEDEX 1 mcg/kg or placebo (normal saline) given over 10 minutes and followed by a fixed maintenance infusion of 0.7 mcg/kg/hr. After achieving the desired level of sedation, topicalization of the airway occurred. Adult patients were allowed to receive rescue midazolam as needed to achieve and/or maintain a Ramsay Sedation Scale ≥2. Demographic characteristics were similar between the PRECEDEX and comparator groups. For efficacy results see Table 16.
| Study | Loading Infusion Treatment Arm | Number of Patients Enrolled* | % Not Requiring Midazolam Rescue | Confidence† Interval on the Difference vs. Placebo | Mean (SD) Total Dose (mg) of Rescue Midazolam Required | Confidence† Intervals of the Mean Rescue Dose |
|---|---|---|---|---|---|---|
Study 1 | Dexmedetomidine | 134 | 40 | 37 (27, 48) | 1.4 (1.7) | -2.7 |
Dexmedetomidine | 129 | 54 |
| 0.9 (1.5) | -3.1 | |
Placebo | 63 | 3 | – | 4.1 (3.0) | – | |
Study 2 | Dexmedetomidine | 55 | 53 | 39 (20, 57) | 1.1 (1.5) | -1.8 |
Placebo | 50 |
| – | 2.9 (3.0) | – | |
Pediatric Patients
The safety and efficacy of PRECEDEX for sedation of non-intubated pediatric patients aged 1 month to less than 17 years undergoing MRI scans was evaluated in one randomized, double-blind, dose-ranging, dose‑controlled multicenter clinical trial utilizing 3 different PRECEDEX dosages. The sedative properties of PRECEDEX were evaluated by age group and by the percent of pediatric patients at the high dose level versus the low dose level who did not require concomitant propofol to complete the MRI scan.
A total of 122 pediatric patients were randomized to the PRECEDEX low dose group (42 of 122), the middle dose group (42 of 122) or the high dose treatment group (38 of 122). All patients received a PRECEDEX loading dose infusion over 10 minutes followed by a maintenance infusion for the duration of the MRI scan (Table 17). If an adequate level of sedation was not achieved within 5 minutes after the start of the PRECEDEX maintenance infusion, patients could receive concomitant propofol as needed based on clinical judgment to achieve and/or maintain adequate sedation.
High Dose | Middle Dose | Low Dose | ||||
Age | Loading Dose (10 min) | Maintenance Dose | Loading Dose (10 min) | Maintenance Dose | Loading Dose (10 min) | Maintenance Dose |
1 month to less than 2 years | 1.5 mcg/kg | 1.5 mcg/kg/h | 1 mcg/kg | 1 mcg/kg/h | 0.5 mcg/kg | 0.5 mcg/kg/h |
2 to less than 17 years | 2 mcg/kg | 1.5 mcg/kg/h | 1.2 mcg /kg | 1 mcg/kg/h | 0.5 mcg/kg | 0.5 mcg kg/h |
The primary efficacy results from this pediatric procedural sedation study are summarized in Table 18. In the combined age group, the percent of pediatric patients not requiring concomitant propofol was 14.3% (6/42) in the low dose group and 63.2% (24/38) in the high dose group. The percentage of patients at the PRECEDEX high dose who completed the MRI without concomitant propofol was statistically greater than the percentage in the PRECEDEX low dose group (p<0.001).
Age Group | High Dose | Middle Dose | Low Dose | High Dose vs Low Dose | ||
n (%) 95% CI* | n (%) 95% CI* | n (%) 95% CI* | Odds Ratio 95% CI† | p-value† | ||
1 month to less than 2 years | N=59 | 9/18 (50.0%) (0.26, 0.74) | 2/21 (9.5%) (0.01, 0.30) | 2/20 (15.0%) (0.03, 0.38) | 0.18 (0.04, 0.82) | 0.022 |
2 to less than 17 years | N=63 | 15/20 (75.0%) (0.51, 0.91) | 13/21 (61.9%) (0.38, 0.82) | 3/22 (13.6%) (0.03, 0.35) | 0.05 (0.01, 0.26) | <0.001 |
Overall | N=122 | 24/38 (63.2%) (0.46, 0.78) | 15/42 (35.7%) (0.22, 0.52) | 6/42 (14.3%) (0.05, 0.29) | 0.10 (0.03, 0.29) | <0.001 |
Secondarily, the sedative properties were also evaluated by examining the percent of time at a target sedation score using the Pediatric Sedation State Scale (PSSS). The PSSS is a validated 6-point scale specifically designed for evaluating pediatric patients undergoing sedation for diagnostic and therapeutic procedures. The PSSS measures the effectiveness and quality of procedural sedation in children. The target sedation level was indicated by a PSSS score of 2 (i.e., patient is quiet [asleep or awake], not moving during procedure, has no frown [or brow furrow] indicating pain or anxiety and no verbalization of any complaint).
In the PRECEDEX high dose group, pediatric patients in both the combined and individual age group were at the target sedation rating scale score (PSSS of 2) for a mean >87% of the time during the PRECEDEX maintenance infusion. In both the combined and individual age group, an increase in the percentage of time at the target sedation rating scale score (PSSS of 2) was observed with increasing PRECEDEX dosage.
{{section_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.