Pain
Conditions
Keywords
Analgesic, Pain Control, IVF, Tylenol, Acetaminophen, Egg Retrieval, iv vitro Fertilization
Brief summary
Current standard of care is no pretreatment medications before the egg retrieval, and the investigators would like to evaluate if preoperative Tylenol improves procedure and post procedure pain control over the current practice (no pre-treatment). Specifically, this study will compare Tylenol with a placebo when given before retrieval procedures. The investigators believe that if Tylenol can offer better analgesic relief than no pretreatment medications, then it may reduce the amount of narcotics needed by patients during and after the procedure and contribute to better patient satisfaction. . This study will enroll 100 participants all from University of Alabama at Birmingham (UAB).
Detailed description
The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well as oxycodone. However, there exists little data of alternatives to narcotic medications for analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013 showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in women undergoing oocyte retrieval. It was also shown that the use of these medications did not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these patients. Few other studies have delved into the question of anesthetics for oocyte retrievals except a prospective study in 2006. This study shows that no significant difference in pregnancy rates of implantation occurs with the use of acetaminophen and diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured in this study for either group. Therefore, it is clear that there exists limited data on the subject of analgesics used in oocyte retrievals for in vitro fertilization and that more exploration into alternative medications is required to find the most effective and least harmful option.
Interventions
DRUGAcetaminophen
Acetaminophen total dose of 1000mg
DRUGplacebo
subjects randomized to this group will be given placebo tablets
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* English Speaking * Undergoing Transvaginal Oocyte Retrieval Procedure
Exclusion criteria
* Acetaminophen allergy * Opioid dependency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | 60 minutes post-procedure | Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure) |
| Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | 24-hours post-procedure | Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | 60-minutes post-procedure | Number of participants requiring use of analgesic medications in the post-operative recovery suite |
| Number of Participants With Use of Analgesics in the First 24 Hours After Discharge | 60-minutes post-procedure to 24-hours after procedure | Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.
placebo: subjects randomized to this group will be given placebo tablets | 31 |
| Experimental Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.
Acetaminophen: Acetaminophen total dose of 1000mg | 33 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Unable to re-consent | 18 | 15 |
Baseline characteristics
| Characteristic | Experimental | Total | Control |
|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 5 | 32.5 years STANDARD_DEVIATION 4.7 | 33 years STANDARD_DEVIATION 4.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 33 participants | 64 participants | 31 participants |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 4 / 31 | 9 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
Median of Cumulative Pain Scores Up to 24 Hours Post Procedure
Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure
Time frame: 24-hours post-procedure
Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | 1 score on a scale |
| Experimental | Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | 2 score on a scale |
Primary
Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure
Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure)
Time frame: 60 minutes post-procedure
Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | 2 score on a scale |
| Experimental | Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | 2 score on a scale |
Secondary
Number of Participants With Use of Analgesics in the First 24 Hours After Discharge
Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure
Time frame: 60-minutes post-procedure to 24-hours after procedure
Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Use of Analgesics in the First 24 Hours After Discharge | 25 Participants |
| Experimental | Number of Participants With Use of Analgesics in the First 24 Hours After Discharge | 27 Participants |
Secondary
Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure
Number of participants requiring use of analgesic medications in the post-operative recovery suite
Time frame: 60-minutes post-procedure
Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | 11 Participants |
| Experimental | Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | 18 Participants |