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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control during medication abortion. This is double-blinded, four-arm randomized controlled trial enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan, narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no narcotics and placebo (microcrystalline cellulose).
Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextromethorphan, opted for narcotic prescription | Experimental | Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) |
|
| Placebo, opted for narcotic prescription | Placebo Comparator | Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) |
|
| Dextromethorphan, declined narcotic prescription | Experimental | Dextromethorphan hydrobromide and patient declines narcotic |
|
| Placebo, declined narcotic prescription | Placebo Comparator | Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | Drug | Dextromethorphan capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst Pain Measurement Via Numeric Rating Scale (NRS-11) | Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible". | Over 24 hours starting from misoprostol administration |
| Analgesic Usage During Medication Abortion | Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication. | Over 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Scores Via Numeric Rating Scale (NRS-11) | Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible". | Marginal mean pain scores over 24 hours |
| Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale |
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Inclusion Criteria:
Exclusion Criteria:
Must be pregnant to participate
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Family Planning Research, Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16781260 | Background | Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. doi: 10.1016/j.contraception.2006.03.002. Epub 2006 May 6. | |
| 10875724 | Background | Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dextromethorphan, Opted for Narcotic Prescription | Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo. |
| FG001 | Placebo, Opted for Narcotic Prescription |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 |
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Randomized Controlled Trial
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|
| Avicel PH101 (Microcrystalline Cellulose NF) for Compounding | Drug | Placebo capsule |
|
|
| Oxycodone | Drug | Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo. |
|
|
Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad" |
| 24 hours after misoprostol administration |
| Planned Parenthood of Western Pennsylvania |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 10939702 | Background | Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand. 2000 Aug;44(7):873-7. doi: 10.1034/j.1399-6576.2000.440715.x. |
| 24735061 | Background | Christie A, Dagfinrud H, Dale O, Schulz T, Hagen KB. Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates. BMC Med Res Methodol. 2014 Apr 16;14:52. doi: 10.1186/1471-2288-14-52. |
| 24553166 | Background | Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-692. doi: 10.1097/01.AOG.0000444454.67279.7d. |
| 36332661 | Derived | Ferguson GP, Achilles SL, Meyn LA, Krajewski CM, Chappell CA, Vinekar K, Chen BA. Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial. Contraception. 2023 Feb;118:109908. doi: 10.1016/j.contraception.2022.10.010. Epub 2022 Nov 2. |
Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo. |
| FG002 | Dextromethorphan, Declined Narcotic Prescription | Dextromethorphan hydrobromide and patient declines narcotic |
| FG003 | Placebo, Declined Narcotic Prescription | Avicel PH101 (Microcrystalline Cellulose NF) and patient declines narcotic |
| COMPLETED |
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| NOT COMPLETED |
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Due to unequal distribution during study conduct, the protocol was modified to recruit all participants rather than into study arms. Data were analyzed as: intervention stratified by narcotic prescription status.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dextromethorphan, With Narcotic Prescription | Participants receiving dextromethorphan and a narcotic prescription |
| BG001 | Placebo, With Narcotic Prescription | Participants receiving placebo and a narcotic prescription |
| BG002 | Dextromethorphan, Declined Narcotic Prescription | Participants receiving dextromethorphan and declined a narcotic prescription |
| BG003 | Placebo, Declined Narcotic Prescription | Participants receiving placebo and declined a narcotic prescription |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Prior medication abortion | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Worst Pain Measurement Via Numeric Rating Scale (NRS-11) | Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible". | Intention to treat population where all participants were analyzed as randomized. Missing worst pain responses were imputed as 10 being the worst pain possible. | Posted | Median | Inter-Quartile Range | score on a scale | Over 24 hours starting from misoprostol administration |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Analgesic Usage During Medication Abortion | Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication. | Missing data are for participants who did not take the specified pain medication | Posted | Median | Inter-Quartile Range | mg | Over 24 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Scores Via Numeric Rating Scale (NRS-11) | Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible". | Posted | Mean | Standard Deviation | score on a scale (NRS-11) | Marginal mean pain scores over 24 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale | Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad" | There are missing data for 3 participants in the dextromethorphan group (1 that opted for a narcotic prescription and 2 that declined) and 3 participants in the placebo (opted for narcotic prescription group). | Posted | Count of Participants | Participants | 24 hours after misoprostol administration |
|
3-5 days after enrollment
Adverse events were collected using text messaging at multiple timepoints (at baseline, misoprostol administration, and 2, 5, 8, and 24 hours after misoprostol) and by phone call 3-5 days later
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dextromethorphan, Opted for Narcotic Prescription | Participants receiving dextromethorphan and opted for a narcotic prescription | 0 | 62 | 1 | 62 | 36 | 62 |
| EG001 | Placebo, Opted for Narcotic Prescription | Participants receiving placebo and opted for a narcotic prescription | 0 | 62 | 0 | 62 | 28 | 62 |
| EG002 | Dextromethorphan, Declined Narcotic Prescription | Participants receiving dextromethorphan and declined a narcotic prescription | 0 | 16 | 0 | 16 | 11 | 16 |
| EG003 | Placebo, Declined Narcotic Prescription | Participants receiving placebo and declined a narcotic prescription | 0 | 16 | 0 | 16 | 8 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Drowsiness | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, MD MPH | University of Pittsburgh | 412-641-5496 | fpr@upmc.edu |
| Jun 17, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| D000111 | Acetylcysteine |
| C109691 | microcrystalline cellulose |
| D002482 | Cellulose |
| D010098 | Oxycodone |
| C514822 | oxycodone-acetaminophen |
| C025153 | Aspirin-oxycodone hydrochloride-oxycodone terephthalate combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
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| Male |
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| Race : Non-Hispanic, White |
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| Hispanic, Black |
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| Hispanic, White |
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| Other |
|
| Other |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Measurements |
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| Title | Measurements |
|---|---|
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