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This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories improve patients' self-reported pain control in the first 24-hours after delivery.
Childbirth is commonly regarded as one of life's most painful experiences and, like childbirth, the postpartum period can also be painful for women. Pain in the immediate postpartum period may significantly affect a woman's overall delivery experience. Pain control is especially important in this period, as women are bonding with their infant and trying to initiate breastfeeding, which may be adversely affected by poor pain management.
Postpartum pain may come from multiple sources. Women experience uterine cramping as a result of uterine involution. Depending on delivery type, women may also have incision pain following cesarean section or perineal pain resulting from episiotomy, perineal tears, or generalized genital trauma during delivery. Perineal pain is common, present in 75% of patients with intact perineum and up to 95-97% with perineal lacerations or episiotomies during the first day after delivery. Commonly employed methods of controlling postpartum pain include opioid analgesics, non-steroidal anti-inflammatories, acetaminophen, and topical analgesics. Pain medication is generally administered via oral or intravenous route. Several studies have investigated suppositories as an alternative method of improving pain following delivery. A double-blinded randomized controlled trial by Wilasrusmee et al (2008) showed naproxen suppositories to be effective for reducing perineal pain after vaginal delivery. Another study showed prophylactic rectal diclofenac to provide effective analgesia after perineal repair, maintained into second and third day postpartum, and a Cochrane Review showed NSAID suppositories to be associated with less pain 24 hours after birth.
Rectal analgesia provides a means of improving pain control through local effects on the perineum and uterus while possibly decreasing systemic absorption, which may in turn decrease systemic side effects and transmission to the newborn infant through breast milk. B&O suppositories contain two medications that could potentially decrease postpartum pain. Morphine, the principle agent in opium, binds opioid receptors and blocks ascending pain pathways. Atropine, a major active component of belladonna, blocks acetylcholine receptors, leading to smooth muscle relaxation. This quality may significantly improve pain from uterine contractions during the postpartum period. The primary aim of our study is to investigate whether belladonna and opium suppositories decrease patient-reported pain in the immediate postpartum period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerin suppository | Placebo Comparator | Women assigned to this arm receive a glycerin suppository (placebo) every 8 hours after delivery during the first 24 hours postpartum |
|
| Belladonna and opioid suppository | Experimental | Women assigned to this arm receive a belladonna and opioid (B&O) suppository every 8 hours after delivery during the first 24 hours postpartum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belladonna and opioid suppository | Drug | Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level Twenty Four Hours After Delivery | The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain). | Twenty-four hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Taking Additional Pain Medications | Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded. | Twenty-four hours |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Kenton, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola Univeristy Medical Center | Maywood | Illinois | 60153 | United States | ||
| Gottlieb Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15507941 | Background | Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064. | |
| 18321517 | Background | Wilasrusmee S, Chittachareon A, Jirasiritum S, Srisangchai P. Naproxen suppository for perineal pain after vaginal delivery. Int J Gynaecol Obstet. 2008 Jul;102(1):19-22. doi: 10.1016/j.ijgo.2008.01.015. Epub 2008 Mar 5. |
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There is no plan to share individual participant data.
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For this study, participants were recruited between August 1, 2009 and October 1, 2011 (26 months)
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycerin Suppository | Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery. |
| FG001 | Belladonna and Opioid Suppository | Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycerin Suppository | Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery. |
| BG001 | Belladonna and Opioid Suppository |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Level Twenty Four Hours After Delivery | The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain). | The 24-hour visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the 24-hour visual analogue pain score for one participant in the Glycerin suppository group is unknown | Posted | Median | Inter-Quartile Range | units on a scale | Twenty-four hours |
|
Adverse event data were collected for 28 months
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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 | Glycerin Suppository | Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
There are no limitations or caveats to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Kenton MD, MS | Northwestern University | 312-472-3874 | kkenton@nm.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
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| Glycerin Suppository | Drug | A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery. |
|
Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).
| Discharge |
| Melrose Park |
| Illinois |
| 60160 |
| United States |
| 9647153 | Background | Searles JA, Pring DW. Effective analgesia following perineal injury during childbirth: a placebo controlled trial of prophylactic rectal diclofenac. Br J Obstet Gynaecol. 1998 Jun;105(6):627-31. doi: 10.1111/j.1471-0528.1998.tb10177.x. |
| 12917995 | Background | Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931. |
| 12098173 | Background | Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90. doi: 10.1053/ajem.2002.33778. |
| 11733293 | Background | Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x. |
| 9428860 | Background | DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020. |
| 33078388 | Derived | Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3. |
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravidity | Median | Inter-Quartile Range | Count of pregnancies |
|
| Parity | The parity count for one participant in the Belladonna and opioid suppository group is unknown | Median | Inter-Quartile Range | Pregnancies to a viable gestational age |
|
| Gestational Age | The gestational age for one participant in the Belladonna and opioid suppository group is unknown, and the gestational age for one participant in the Glycerin suppository group is unknown | Mean | Standard Deviation | Weeks |
|
| Route of Delivery | Count of Participants | Participants |
|
| Breastfeeding | Count of Participants | Participants |
|
| Visual Analogue Scale Pain Score | Patients' baseline Visual Analog Scale (VAS) pain score was recorded at 0 hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain). | The baseline visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the baseline visual analogue pain score for one participant in the Glycerin suppository group is unknown | Median | Inter-Quartile Range | units on a scale |
|
| Belladonna and Opioid Suppository |
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery |
|
|
|
| Secondary | Number of Patients Taking Additional Pain Medications | Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded. | Posted | Count of Participants | Participants | Twenty-four hours |
|
|
|
|
| Secondary | Patient Satisfaction | Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied). | The pain satisfaction at discharge score is unknown for eight participants in the Belladonna and opioid suppository group, and the pain satisfaction at discharge score is unknown for six participants in the Glycerin suppository group. | Posted | Median | Inter-Quartile Range | units on a scale | Discharge |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 22 |
| 48 |
| EG001 | Belladonna and Opioid Suppository | Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery | 0 | 52 | 0 | 52 | 23 | 52 |
| Difficulty Urinating | Renal and urinary disorders | Non-systematic Assessment |
|
| Sensitivity to Light | Eye disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Blurred Vision | Eye disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Emesis | General disorders | Non-systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| Unknown or Not Reported |
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| Breastfeeding is unknown or not reported |
|