Pain
Conditions
Keywords
Belladonna, Opium, Suppository
Brief summary
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.
Detailed description
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.
Interventions
DRUGBelladonna and opioid suppository
Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola University Medical Center * \> 34 weeks gestation at time of delivery * \> 18 years old * No known allergy to belladonna, opium, or vegetable oil suppositories * Able to consent and complete study documents
Exclusion criteria
* Chronic pain condition or on narcotic medication prior to admission * Contraindications to B&O suppositories, including patients with glaucoma, severe hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory depression; convulsive disorders; acute alcoholism; delirium tremens; history of hypersensitivity to any component of product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level Twenty Four Hours After Delivery | Twenty-four hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Taking Additional Pain Medications | Twenty-four hours | Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded. |
| Patient Satisfaction | Discharge | 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). |
Countries
United States
Participant flow
Recruitment details
For this study, participants were recruited between August 1, 2009 and October 1, 2011 (26 months)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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 | 52 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Glycerin Suppository | Belladonna and Opioid Suppository |
|---|---|---|---|
| Age, Continuous | 29.34 years STANDARD_DEVIATION 5.74 | 29.40 years STANDARD_DEVIATION 5.78 | 29.29 years STANDARD_DEVIATION 5.76 |
| Breastfeeding Breastfeeding | 78 Participants | 37 Participants | 41 Participants |
| Breastfeeding Breastfeeding is unknown or not reported | 5 Participants | 3 Participants | 2 Participants |
| Breastfeeding Not Breastfeeding | 17 Participants | 8 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 17 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 24 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants | 7 Participants | 11 Participants |
| Gestational Age | 38.89 Weeks STANDARD_DEVIATION 1.16 | 38.68 Weeks STANDARD_DEVIATION 1.24 | 39.09 Weeks STANDARD_DEVIATION 1.05 |
| Gravidity | 2 Count of pregnancies | 2.5 Count of pregnancies | 2 Count of pregnancies |
| Parity | 1 Pregnancies to a viable gestational age | 1 Pregnancies to a viable gestational age | 1 Pregnancies to a viable gestational age |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Other Race | 9 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 28 Participants | 15 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 24 Participants | 25 Participants |
| Region of Enrollment United States | 100 participants | 48 participants | 52 participants |
| Route of Delivery Cesarean | 27 Participants | 17 Participants | 10 Participants |
| Route of Delivery Normal spontaneous vaginal delivery (NSVD) | 73 Participants | 31 Participants | 42 Participants |
| Sex: Female, Male Female | 100 Participants | 48 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Visual Analogue Scale Pain Score | 0 units on a scale | 0 units on a scale | 0 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 52 |
| other Total, other adverse events | 22 / 48 | 23 / 52 |
| serious Total, serious adverse events | 0 / 48 | 0 / 52 |
Outcome results
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).
Time frame: Twenty-four hours
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Glycerin Suppository | Pain Level Twenty Four Hours After Delivery | 1 units on a scale |
| Belladonna and Opioid Suppository | Pain Level Twenty Four Hours After Delivery | 2 units on a scale |
Comparison: The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.p-value: 0.35Wilcoxon (Mann-Whitney)
Secondary
Number of Patients Taking Additional Pain Medications
Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.
Time frame: Twenty-four hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glycerin Suppository | Number of Patients Taking Additional Pain Medications | Taking additional pain medications | 40 Participants |
| Glycerin Suppository | Number of Patients Taking Additional Pain Medications | Not taking additional pain medications | 8 Participants |
| Belladonna and Opioid Suppository | Number of Patients Taking Additional Pain Medications | Taking additional pain medications | 47 Participants |
| Belladonna and Opioid Suppository | Number of Patients Taking Additional Pain Medications | Not taking additional pain medications | 5 Participants |
Comparison: The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.p-value: 0.395% CI: [0.57, 6.21]Regression, Logistic
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).
Time frame: Discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Glycerin Suppository | Patient Satisfaction | 4 units on a scale |
| Belladonna and Opioid Suppository | Patient Satisfaction | 5 units on a scale |
Comparison: The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at dischargep-value: 0.02Wilcoxon (Mann-Whitney)