| Primary | Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. | To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured. | | Posted | | Mean | Standard Deviation | fentanyl doses | | 4 hours | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.5± 1.32
- OG0011.7± 1.12
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| Secondary | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. | The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain. | Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure. | Posted | | Mean | Standard Deviation | millimeters | | 30 minutes post-procedure | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. | To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain. | Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure. | Posted | | Mean | Standard Deviation | millimeters | | 60 minutes post-procedure | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure. | o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain. | Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure. | Posted | | Mean | Standard Deviation | millimeters | | 90 minutes post-procedure | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure. | To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain. | Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure. | Posted | | Mean | Standard Deviation | millimeters | | 120 minutes post-procedure | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Time to Discharge Post Procedure. | To evaluate the secondary objective of pain, the time to participant discharge will be measured. | | Posted | | Mean | Standard Error | hours | | Discharge | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Time to Swallow Post Procedure. | Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded. | | Posted | | Mean | Standard Error | hours | | every 15 minutes until able to swallow | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Parent Satisfaction With Regards to Pain Management Post Procedure. | To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked "How satisfied were you with your child's pain management at the time of discharge?" | Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge? | Posted | | Number | | participants | | Discharge | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Parent Satisfaction With Regards to Nausea Management Post Procedure. | To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked "How satisfied were you with your child's nausea management during the study?" | Summary of Satisfaction Post-Procedure with nausea management during the study | Posted | | Number | | participants | | Discharge | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked "How satisfied were you with your child's vomiting management during the study?" | Summary of Satisfaction Post-Procedure with Vomiting Control. | Posted | | Number | | participants | | Discharge | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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| Secondary | Blood Loss During Surgery | Amount of Blood Lost During Surgery in milliliters | Blood loss during surgery in milliliters | Posted | | Mean | Standard Deviation | milliliters | | End of Surgery | | | | ID | Title | Description |
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| OG000 | Intravenous Ibuprofen | Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | | OG001 | Normal Saline | Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
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