Endometriosis of uterus
Conditions
Interventions
The study enrolled 84 women, over 18 years old and scheduled for elective abdominal hysterectomy. Patients were randomly allocated in two groups (1:1 ratio) using computer-generated random numbers. Gr
Drug
Sponsors
Hospital São José do Avaí
Santa Casa de Belo Horizonte - Ensino e Pesquisa
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study enrolled women; over 18 years old; scheduled for elective abdominal hysterectomy at Hospital São José do Avaí; ASA I-III patients.
Exclusion criteria
Exclusion criteria: patients unlikely to be fully cooperative during the study; allergy to dipyrone/ketoprofen; non-indication for spinal anesthesia; cognitive impairment; severe renal impairment; lack of consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary outcome 1 Postoperative pain. Times 4, 12 and 24 hours after surgery. The pain was measured by a numeric pain scale (0 to 10, wherein 0 represented no pain and 10 the worst possible pain). We expected lower pain scores in ketamine group in comparison with morphine group;Observed primary outcome 1 Ketamine group reported higher pain scores than the morphine group at 12 hours post-surgery. Data is presented bellow. 4hs (average +_ Standard deviation) 5.7 +-3.3 vs 5.0 +-3.6, non-significant, morphine and ketamine, respectively. 12hs (average +_ deviation) 4.8+-2.7 vs 6.8+-2.9 P equal to 0.004, morphine and ketamine, respectively. 24hs (average +_ deviation) 3.5+-2.8 vs 3.4+-2.7, non-significant, morphine and ketamine, respectively.;Expected primary outcome 2 Amount of tramadol (opioid analgesic) in milligrams, given to patients in the postoperative recovery room. We expected higher amounts of tramadol in the morphine group.;Observed primary outcome 2 Ketamine group received more tramadol than morphine group at the time of 12 hours postsurgery. 71 vs 42 mg of tramadol, ketamine and morphine groups, respectively (p equal to 0.01). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome 2 Postoperative nausea and vomiting. Measured at times 4, 12 and 24 hours after surgery in the recovery room. The recording was made through the PONV scale (postoperative nausea and vomiting scale) ranging from 1 to 3 (1 equal to mild, 2 equal to moderate and 3 equal to severe). We expected lower nausea and vomiting scores in ketamine group.;Observed secondary outcome 2 No differences were observed between morphine and ketamine groups in the PONV scale.;Expected secondary outcome 3 Pruritus. Metric: occurrence or non-occurrence in (% of cases). It was measured at 4, 12 and 24 hours after surgery in the recovery room. We expected lower pruritus incidence in ketamine group.;Observed secondary outcome 3 Morphine group had a higher prevalence of pruritus (20%) at time 12 hs than the ketamine group (5%, p equal to 0.04).;Expected secondary outcome 4 Urinary retention. Metric: occurrence or non-occurrence in (% of cases). It was measured at 24 hours after surgery in the recovery room. We expected not seeing significant differences between groups. ;Observed secondary outcome 4 There was no difference in the prevalence of urinary retention between morphine and ketamine groups at the time analyzed.;Expected Secondary outcome 5 Change in Bowel habits. Metric: occurrence or non-occurrence in (% of cases). It was measured at 24 hours after surgery in the recovery room. We expected not seeing significant differences between groups. ;Observed secondary outcome 5 There was no difference in the prevalence of urinary retention between morphine and ketamine groups at the time analyzed.;Expected secondary outcome 1 Consumptions of vasopressors Phnylefrine (micrograms) and atropine (miligrams) whithin the surgery. We expected not seeing significant differences between groups.;Observed secondary outcome 1 Averaged phenylefrine and atropine consumptions were similar between morphine and ketamine groups. Phenylefrine 312 vs 337 morphine and ketami | — |
Countries
Brazil
Contacts
Public ContactCamila Carpi
Hospital São José do Avaí
Outcome results
None listed