Pain and Medical Abortion Among Teenaged Women Compared to Adult Women

NCT02678897 | Completed Phase 4 DMC

• 3 other identifiers: HUS277/03/20152015-003760-362015-005657-12
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 2

Brief Summary

In this two-parted study the need and sufficiency of analgesics and experienced pain is compared between teen-aged and adult women undergoing medical termination of pregnancy (MToP)in early pregnancy (under 9weeks of gestation). During MToP at pregnancy weeks 9-20 on-demand administration of opiates and patient-controlled analgesia (PCA) are compared in randomized clinical trial.

Conditions

Pain

Keywords

Abortion, Drug-Induced; Pain Management

Outcome Measures

Primary Outcomes (1)

• Patients are less painful using patient controlled analgesia (PCA)

  Measured in visual analog scale (VAS, 0-100mm). VAS is lower.

  During drug-induced abortion, in hospital care (1-2days)

Secondary Outcomes (1)

• Patient satisfaction is higher

  just after the abortion and 2-3 weeks after in follow-up visit

Other Outcomes (2)

• Teen-aged women experience more severe pain than their adult comparators.

  during drug-induced abortion

• Patients with history of dysmenorrhea or anxiety experience more severe pain during drug-induced abortion.

  During drug-induced abortion

Study Arms (3)

Pain management in early pregnancy MTOP

NO INTERVENTION

Patients in early pregnancy (pregnancy weeks \<9weeks) undergoing medical termination of pregnancy gets Ibuprofen (tbl 600mg 3 times a day) and Paracetamol (tbl 1000mg 3 times a day).

Patient controlled analgesia (PCA)

EXPERIMENTAL

Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get pain medication (Oxynorm) via PCA

Drug: Oxynorm via PCA

Oxynorm on-demand

ACTIVE COMPARATOR

Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get extra pain medication (Oxynorm) on-demad from the nurse.

Drug: Oxynorm on-demand

Interventions

Oxynorm on-demand DRUG

We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication) 1. If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po. In an hour oxycodon 5-10 mg more po if needed. Intramuscular or intravenous administration if needed. 2. Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock-out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.

Oxynorm on-demand

Oxynorm via PCA DRUG

We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication) 1. If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po. In an hour oxycodon 5-10 mg more po if needed. Intramuscular or intravenous administration if needed. 2. Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock-out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.

Patient controlled analgesia (PCA)

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who choose medical method of abortion
• First pregnancy
• Age between 15 and 19 years or 25 and 35 years
• Patients volunteer in the study

You may not qualify if:

• Patient's serious illness
• Known allergy to one of the trial medications
• Abortion is done based on foetal abnormality or threat of patient's own health
• Abortion is done based on foetal abnormality or threat of patient's own health
• Minor patient does not want to inform guardian
• More than one foetus
• Patient's serious illness (ASA-class 3 or 4)
• Massive obesity (BMI \>35 kg/m2)
• Known allergy to one of the trial medications
• History of opioid abuse
• Problems of understanding (Inability of use PCA or to understand VAS)
• Active bleeding before intake of first Misoprostol dose
• One of next medications: ketokonatsol, erythromycin, claritromycin, verapamil or diltiazem or medication against HIV (CYP3A4-transmitted interaction with oxycodon)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (2)

Helsinki University Central hospital, Kätilöopistohospital

Helsinki, HUS, 00029, Finland

Location

Helsinki University central hospital, Naistenklinikka

Helsinki, HUS, 00029, Finland

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Oskari Heikinheimo, Professor

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: February 10, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 31, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)