Mayo Clinic
Phoenix, Arizona, 85054, United States
NCT Number: NCT01150474
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
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Notify Me18 year and older
Female
Interventional
Phase 4
Phoenix, Arizona, 85054, United States
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.
A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Other names: B & O Supprettes
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Time frame: 4 hours following surgery
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Time frame: 12 hours after surgery.
Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Time frame: 20 hours after surgery.
Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Time frame: For 24 hours following surgery
Use of all ancillary narcotic medications was taken from the medical record.
Time frame: Approximately 12 hours after surgery
This information was taken from the medical record.
Time frame: Within 20 hours of surgery
This information was taken from the medical record.
Time frame: First 24 hours after surgery
Time frame: First 24 hours after surgery
Time frame: Approximately 24 hours following surgery
Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied."
Kristina A. Butler
Other
Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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