Neonatal Diseases Pregnancy and Childbirth Respiratory Analgesia in labour Anaesthesia
Conditions
Interventions
tramadol
Sponsors
Philip Ikechukwu Ugota
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Primigravid or multigravid women in active labour (cervical dilatation 4-8 cm). • Gestational age of 37--42 weeks. • Singleton pregnancy with a cephalic presentation. • Pain score of 5 on a 10-point Visual Analogue Scale requesting pain relief. • Haemodynamically stable. • Age 18-44 years. • Ability to understand and provide informed consent.
Exclusion criteria
Exclusion criteria: • Known allergy or contraindication to tramadol or pentazocine. • Known opioid dependence or chronic opioid use. • Pre-existing medical conditions (e.g., severe cardiac, renal, hepatic, or neurological disease, uncontrolled hypertension, pre-eclampsia, eclampsia, or gestational diabetes requiring insulin) that might affect drug metabolism or neonatal outcomes. • Any obstetric complications (e.g., antepartum haemorrhage, placenta praevia, abruptio placentae, severe intrauterine growth restriction, chorioamnionitis). • Evidence of foetal distress requiring immediate intervention. • History of psychiatric illness or known psychotomimetic tendencies. • Contraindication to intramuscular injections. • Women who have received any systemic analgesia or regional analgesia during the current labour.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| . Primary Outcome Measure: •Analgesic Efficacy: Measured by changes in pain intensity using a 10-point VAS at baseline, 15, 30, 60, 90, and 120 minutes post-administration, and hourly thereafter until delivery. Total pain relief and peak pain relief will also be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: • Maternal Adverse Effects: Incidence and severity of adverse effects (e.g., nausea, vomiting, dizziness, sedation using a sedation score, pruritus, psychotomimetic effects like dysphoria or hallucinations) recorded hourly for 4 hours post-administration. | — |
Countries
Nigeria
Contacts
Public ContactAnthony Nweze
Senior Registrar Department of Obstetrics and Gynaecology University of Nigeria teaching Hospital Ituku Ozalla Enugu
Outcome results
None listed