PainPhase 4CRAMPSNCT01271855
Assessing Maternal Post-partum Pain With Suppositories
A Phase 4 study testing Belladonna and opioid suppository and Glycerin Suppository in people with Pain, run by Loyola University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Belladonna and opioid suppository and Glycerin Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2009to 29 Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loyola Univeristy Medical Center
Maywood, Illinois, 60153
Gottlieb Memorial Hospital
Melrose Park, Illinois, 60160
About this study
Official title: CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Belladonna and opioid suppository, Glycerin Suppository
- Keywords
- Belladonna, Opium, Suppository
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belladonna and opioid suppositoryDrug
Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
Glycerin SuppositoryDrug
A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Glycerin Suppository |
| 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 Receives: Drug: Belladonna and opioid suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Twenty-four hours
Secondary outcomes (2)
Number of Patients Taking Additional Pain Medications
Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.
Measured: Twenty-four hours
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).
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study start22 Jul 2009
- Primary completion29 Sep 2011
- Study completion29 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Kenton, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271855
- Sponsor's protocol ID
- 201720
- Acronym
- CRAMPS
- Status last verified
- Feb 2018
- First submitted
- 5 Jan 2011
- Last updated
- 7 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
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.
PubMed 15507941Wilasrusmee 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.
PubMed 18321517Searles 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.
PubMed 9647153Hedayati 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.
PubMed 12917995Gallagher 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.
PubMed 12098173Bijur 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.
PubMed 11733293DeLoach 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.
PubMed 9428860Deussen 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.
PubMed 33078388
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories
- ClinicalTrials.gov ID
- NCT01271855
- Acronym / sponsor ID
- CRAMPS / 201720
- Conditions
- Pain
- Keywords
- Belladonna, Opium, Suppository
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 22 Jul 2009 (actual)
- Primary completion
- 29 Sep 2011 (actual)
- Study completion
- 29 Sep 2011 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Posted 6 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Glycerin suppository | Placebo comparator | Drug: Glycerin SuppositoryWomen 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 | Drug: Belladonna and opioid suppositoryWomen assigned to this arm receive a belladonna and opioid (B\&O) suppository every 8 hours after delivery during the first 24 hours postpartum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belladonna and opioid suppositoryBelladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery | Drug | Belladonna and opioid suppository |
| Glycerin SuppositoryA vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery. | Drug | Glycerin suppository |
Primary outcome
Pain Level Twenty Four Hours After Delivery
Time frame: 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).
2 secondary outcomes
Number of Patients Taking Additional Pain Medications
Time frame: Twenty-four hours
Patient Satisfaction
Time frame: Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15507941Macarthur 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.
- Background: PubMed 18321517Wilasrusmee 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.
- Background: PubMed 9647153Searles 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.
- Background: PubMed 12917995Hedayati 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.
- Background: PubMed 12098173Gallagher 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.
- Background: PubMed 11733293Bijur 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.
- Background: PubMed 9428860DeLoach 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.
- Derived from this study: PubMed 33078388Deussen 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Kenton, M.D. principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belladonna and opioid suppository and Glycerin Suppository in people with Pain, run by Loyola University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level Twenty Four Hours After Delivery (time frame: Twenty-four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271855, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.