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A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia

NCT06371144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-04-17

No results posted yet for this study

Summary

ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects.

OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs.

METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded.

10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects.

Conditions

Interventions

DRUG

Paracetamol

Analgestic

Sponsors & Collaborators

  • Darlington-Peter Chibuzor Ugoji

    lead OTHER

Principal Investigators

  • OGBO DR UZOMA, MBBS · Alex Ekwueme Federal University Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2022-09-10
Completion
2022-09-10

Countries

  • Nigeria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371144 on ClinicalTrials.gov