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Withdrawn - no participants enrolled
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This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose epidural morphine | Active Comparator | One dose of 1.25 mg epidural morphine |
|
| High dose epidural morphine | Active Comparator | One dose of 2.5 mg epidural morphine |
|
| Saline | Placebo Comparator | One dose of 10 ml saline administered through an epidural catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | Comparison of different dosages of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total breakthrough opioid consumption | First 24 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores at rest | At 6, 12, 24, and 36 h after delivery | |
| Pain scores with movement | At 6, 12, 24, and 36 h after delivery | |
| Severity of nausea/vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudha I Singh, MD FRCPC | The University of Western Ontario | Principal Investigator |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Placebo | Drug |
|
| At 6, 12, 24, and 36 h after delivery |
| Severity of pruritis | At 6, 12, 24, and 36 h after delivery |
| Severity of sedation | At 6, 12, 24, and 36 h after delivery |
| Time to first request for additional analgesia | First 36 h after delivery |
| Patient satisfaction with pain control | At 24 and 36 h after delivery |
| Quality of Recovery | At 24 and 36 h after delivery |
| Antiemetic consumption | First 36 h after delivery |
| Antipruritic medication consumption | First 36 h after delivery |
| Total opioid consumption | First 36 h after delivery |
| 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 |