Dilation and evacuation is the most common technique used for second-trimester abortion. Pre-operative dilation of the cervix with the use of osmotic dilators decreases the risk of complications, and evidence-based research supports their use. Dilators remain in place for hours, often overnight, and expand; hence many women require overnight analgesia. Prescribing patterns are variable: women may or may not receive opioids for pain control, and this variability is provider dependent. Clinical data to inform best practices in this area are lacking.
We propose a pilot randomized trial, to compare prescription for ibuprofen alone with ibuprofen + oxycodone for overnight analgesia, among women receiving osmotic dilators. We will use a text messaging platform to record real-time pain scores, and collect information regarding the timing and type of therapies used between dilator insertion and evacuation procedure. The primary outcome will be maximum pain scores during the period of time the osmotic dilators are in place.
Our primary aim is to compare maximum overnight pain scores between women randomized to receive ibuprofen alone to those randomized to receive ibuprofen + oxycodone in the setting of osmotic dilator placement for dilation and evacuation. For this pilot study, we will use a convenience sample of 70 participants. Based upon our clinical volume we anticipate it will be feasible to recruit 70 participants within a 6-month time period. We aim to obtain the point estimates of the mean, median and standard deviations of maximum pain scores among those randomized to ibuprofen alone, compared to those randomized to ibuprofen and oxycodone. A Numerical Rating System (NRS; 0-10) score will be used to measure this outcome. A difference of 1.3 between maximum pain scores, as defined in prior literature, would be clinically meaningful.