Not Yet RecruitingPhase 2ACTRN12612000117819

Efficacy of melatonin for postoperative pain relief and reduced blood loss after cesarean section

Evaluation of melatonin's effect on pain and blood loss after cesarean section


Sponsor

Qazvin Medical Science University

Enrollment

120 participants

Start Date

Feb 1, 2012

Study Type

Interventional

Conditions

Summary

To assess effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer’s solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determiniation of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 42 Yearss

Inclusion Criteria2

  • pregnant women at term (37—40 wks) gestation scheduled for either elective or emergency lower segment cesarean
  • section .

Exclusion Criteria3

  • excluding criteria:Women with any risk factor
  • associated with an increased risk of postpartum
  • hemorrhage were excluded i.e. anemia (Hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus, current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

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Interventions

One hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly

One hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer’s solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused .


Locations(1)

Qazvin, Iran, Islamic Republic Of

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