The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. Each patient was assigned to a weight-based dose arm, between 3.5mcg/kg-7.0mcg/kg or up to a maximum of 400 mcg. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level. ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was \>5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
2.5 mcg/kg intrathecal
2.75 mcg/kg intrathecal
3 mcg/kg intrathecal
Mayo Clinic Rochester
Rochester, Minnesota, United States
Pain Intensity (Area Under the Curve Pain)
Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule.
Time frame: 18 hours after intrathecal hydromorphone administration
Number of Subjects Needing Dual Anti-pruritic Agents
The number of subjects who needed dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min)).
Time frame: 24 postoperative hours
Maximum Pain Scores
Highest pain score reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with total scores ranging from 0=no pain and 10=worst pain ever with higher scores indicating more severe pain.
Time frame: 18 hours after intrathecal hydromorphone administration
Oral Morphine Equivalents Consumption
Total oral morphine equivalents (OME) consumption in the first 24 hours after intrathecal hydromorphone administration. Intrathecal hydromorphone will be included in total oral morphine equivalents consumption.
Time frame: 24 hours after intrathecal hydromorphone administration
Number of Subjects Needing Antiemetic Medications Postoperatively
The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting.
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3.25 mcg/kg intrathecal
3.5 mcg/kg intrathecal
4 mcg/kg intrathecal
4.5 mcg/kg intrathecal
5 mcg/kg intrathecal
5.5 mcg/kg intrathecal
6 mcg/kg intrathecal
6.5 mcg/kg intrathecal
7 mcg/kg intrathecal
Time frame: 24 postoperative hours